MAUDE Adverse Event Report: ETHICON INC. TPW 24IN 2-0 D/A SH,SKS-3 BWY; ELECTRODE, PACEMAKER, TEMP

Catalog Number	TPW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain 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.Please confirm the number of procedures affected by this issue? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Please confirm the number of devices affected per procedure.Can you identify the lot number of the product that was used? when did the wire break (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify were there any patient consequences? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned related events captured via: 2210968-2024-03584.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The hospital has noticed the tpw30 pacing wire 2-0 wires breaking more than usual.There was no patient consequence.Additional information was requested.

• Brand Name: TPW 24IN 2-0 D/A SH,SKS-3 BWY
• Common Device Name: 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 ; 9083863534
• MDR Report Key: 18994829
• Report Number: 2210968-2024-03583
• Device Sequence Number: 18043687
• Product Code: LDF
• UDI-Device Identifier: 10705031050884
• UDI-Public: 10705031050884
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: TPW30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown