MAUDE Adverse Event Report: ETHICON, LLC TEMPORARY CARDIAC PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number TPW32

Device Problems Disconnection (1171); Fracture (1260); Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Ethicon temporary cardiac pacing wire 2-0 (tpw32).Fraying/facture at the point where the flexible pacing wire meets the rigid metal pin.Flexible pacing wire became completely disconnected from metal pin (portion where pacing wires connect to cables that connect to pacing box).Two events occurred with two different patients (different sets of wires) in 2021.Recommendations: connection point where wire meets rigid metal pin is vulnerable site for stress and subsequent fracture.Consider reinforcement to prevent recurrent device failure.

• Brand Name: TEMPORARY CARDIAC PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 13224071
• MDR Text Key: 283611585
• Report Number: 13224071
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Sex: Female
• Patient Weight: 5 KG