MAUDE Adverse Event Report: ETHICON INC. TPW 2X24IN 2-0 D/A SH,SKS-3 BWY; ELECTRODE, PACEMAKER, TEMP

Model Number TPW32

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).(b)(6).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was any surgical intervention performed due to the event? if yes, date and details were pacing wires removed on 6/14 in re-operation? please specify.If available, please provide a product lot number.

Event Description

It was reported that the patient underwent a heart transplant surgery on (b)(6) 2021 and temporary pacing wire was used.On 6/9 the rn reported to unit cns/crn that the v wire was completely broken off from pin at connection site.Exact date of break is unknown.Pacing wires were removed on 6/14.No known harm to patient.There were no patient consequences reported.Additional information has been requested.

• Brand Name: TPW 2X24IN 2-0 D/A SH,SKS-3 BWY
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12158202
• MDR Text Key: 261346411
• Report Number: 2210968-2021-06261
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1