HT Connect Peripheral Guidewire

## Medical Device Alert: HT Connect Peripheral Guidewire Recall - Policy Analysis Report **1. Executive Summary:** This report analyzes a medical device alert issued by the Central Drugs Standard Control Organization (CDSCO) on December 10, 2013, concerning a voluntary field action (recall) for HT Connect Peripheral Guidewires. The core purpose is to inform users of a potential defect – partial delamination of the PTFE coating – in specific lots of these guidewires and advise on corrective actions. Key findings include the identification of affected product codes and lot numbers, potential risks associated with the defect, and contact information for reporting incidents and obtaining further information. **2. Introduction:** This report aims to provide a comprehensive overview of the medical device alert issued by the CDSCO regarding the HT Connect Peripheral Guidewire recall, based solely on the information provided in the policy text. It focuses on outlining the nature of the alert, the reasons behind it, the products affected, and relevant contact information for stakeholders. **3. Policy Overview:** This document constitutes a medical device alert. The core objective is to immediately inform healthcare providers and users about a potential safety issue with the listed HT Connect Peripheral Guidewires, specifically the risk of PTFE coating delamination, and to initiate a voluntary field action to remove affected devices from circulation. **4. Background and Rationale:** This is a new alert concerning a specific product defect. The policy addresses a potential problem with the Hi Torque Connect Peripheral Guidewire, where a small number of devices have exhibited partial delamination of the PTFE coating. This defect could potentially lead to adverse events during medical procedures, justifying the product recall. The text indicates worldwide reported incidents of delamination, implying a broad, international nature to the issue. **5. Key Provisions / Changes:** This is a new alert, not an amendment. Therefore, the provisions are the specific directives outlined in the alert itself: * **Product Identification:** Specific part numbers and lot numbers of the affected HT Connect Peripheral Guidewires are clearly identified. These include various lengths and flexibilities of the Hi Torque Connect, Hi Torque Connect Flex, and Hi Torque Connect 250T models, all sharing lot number 018. * **Nature of the Defect:** The alert highlights the issue of partial delamination of the PTFE coating of the guidewire. * **Usage Context:** The guidewires are indicated for facilitating the placement of percutaneous devices during percutaneous transluminal angioplasty in peripheral arteries. * **Corrective Action:** The alert mandates a voluntary field action, meaning a recall of the affected devices. Medical facilities are advised to remove and return suspect devices from their inventory. * **Reporting and Contact Information:** The alert provides contact details for Abbott Vascular (US and India), and the Directorate General of Health Services (India) to report issues, seek further information, or handle complaints. **6. Target Audience and Stakeholders:** The primary target audience includes: * **Healthcare Professionals:** Physicians, surgeons, and interventional radiologists who utilize HT Connect Peripheral Guidewires during angioplasty procedures. * **Hospitals and Clinics:** Medical facilities that have purchased and stocked the identified lots of HT Connect Peripheral Guidewires. * **Supply Chain and Distributors:** Entities involved in the distribution and supply of these medical devices. * **Manufacturers:** Abbott Vascular, specifically the entities mentioned in the alert with contact information, as they are responsible for the voluntary field action. * **Patients:** While not directly addressed, patients undergoing procedures using these guidewires are indirectly affected as the recall aims to prevent potential complications. **7. Implementation Aspects (Inferred):** * **Responsible Agencies/Bodies:** CDSCO (issuing authority), Abbott Vascular (responsible for the recall). * **Timelines/Procedures:** The alert implicitly requires immediate action by healthcare providers to identify and remove affected devices. The procedure involves contacting Abbott Vascular for instructions on returning the recalled product. * **Corrective Action:** Facilities need to identify the impacted products and return it to the company. **8. Expected Outcomes / Impact of Changes:** The intended outcomes of this alert and the associated voluntary field action are: * **Reduced Risk:** Mitigation of potential adverse events, such as thromboembolism or additional interventions due to coating delamination during medical procedures. * **Improved Patient Safety:** Ensuring that healthcare professionals are aware of the potential defect and can take appropriate precautions. * **Market Confidence:** Maintaining confidence in the quality and safety of medical devices by promptly addressing identified issues. * **Adherence to Regulations:** Compliance with regulatory requirements for medical device safety and reporting. **9. Conclusion:** The CDSCO's medical device alert regarding the HT Connect Peripheral Guidewire recall highlights a significant safety concern related to PTFE coating delamination. The alert necessitates immediate action from healthcare providers and facilities to identify and remove affected devices from circulation, thereby mitigating potential risks to patients and maintaining the integrity of medical procedures. The information presented in this report, derived solely from the provided text, emphasizes the importance of vigilance and responsiveness in addressing medical device safety issues.

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