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	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.What do you mean by "a small fragment of a wire remain"? please clarify.Did any fragment of wire remains in patients body? please confirm.Did the patient suffer from any consequence due to the issue? please provide more details.What is the lot number? 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, or its employees that the report constitutes an admission that the product, ethicon, 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.
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 physician¿s assistant stated that they recently had a small fragment of a wire remain following a pacing wire pull.No adverse patient consequences were reported.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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15349109
• Report Number: 2210968-2022-07254
• Device Sequence Number: 12063733
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: 08/09/2022
• Initial Report FDA Received Date: 09/02/2022
• 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 Age: 3 YR
• Patient Sex: Female