MAUDE Adverse Event Report: ETHICON, LLC TEMPORARY CARDIAC PACING WIRE MULTIFILAMENT 316L COATED WITH BLUE POLYETHYLENE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number TPW32

Device Problem Break (1069)

Patient Problem Dizziness (2194)

Event Date 05/23/2021

Event Type  malfunction  

Event Description

(b)(6) 2021: epicardial wires broke where they insert into the needle.Harm did not occur, but could occur if we needed the wires and the device was broken.This has occurred as well with two other recent patients: neither resulted in harm.(b)(6) 2021: patient was waiting in the icu for ppm placement and the ventricular epicardial wire broke where is connects to the needle.Patient was lightheaded, blood pressure stable.External pacing pads were placed on the patient.(b)(6) 2021: temporary epicardial pacing wire (atrial) broken apart from where wire connects to the needle (insertion metal).(b)(6) 2021: temporary epicardial v lead pacing wire broke at pin connection.Exact date of breakage unknown but was passed on in report today that wire was broken.Epicardial wires were pulled today by transplant np as planned.(b)(6) 2021: broken pacer wire occurred sometime in icu between (b)(6) and (b)(6).(b)(6) 2021: rn noticed on monitor that patient had stopped pacing.It was discovered that the a wire was broken.The pin was still in the pacer box but wire had broken off.Site care had been done earlier in shift and wires were functioning and intact.No harm to patient, underlying rhythm ok.(b)(6) 2021: pacer maker wire broke off metal end.

• Brand Name: TEMPORARY CARDIAC PACING WIRE MULTIFILAMENT 316L COATED WITH BLUE POLYETHYLENE
• 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: 11937969
• MDR Text Key: 254260178
• Report Number: 11937969
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1