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

Model Number	TPW32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: what was the name of the procedure?- no procedure involved at time of issue.What was the procedure date? n/a.Have any of these events been previously reported to ethicon? not from my department.What is the lot number? copied our supply chain for this (mark) what was used to complete the procedure? n/a.Was there any adverse patient outcome? none- only delay in being able to cardiac pace patient.If yes, was there any medical or surgical intervention performed? what is the patient¿s current status? n/a.Device return status n/a.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and temporary pacing wire was used.The wire fractured at the junction of the metal blunt needle and wire.Due to the issue, there was delay in being able to cardiac pace the patient, however, there were no adverse patient consequences.Additional information was requested.

• Brand Name: TPW 2X24IN 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
• MDR Report Key: 12287877
• Report Number: 2210968-2021-07070
• Device Sequence Number: 3682755
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1