MAUDE Adverse Event Report: ETHICON INC. TPW 2X24IN 2-0 D/A BB-1,SKS-3 BWY; ELECTRODE, PACEMAKER, TEMP

Model Number	TPW42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2022
Type of Reportable Event	Serious Injury
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.Attempts are being made to retrieve the device.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.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender, weight at the time of index procedure: gender unknown, 3 months old, 4.58 kilos.Name of index surgical procedure? unknown, but some type of open heart surgery.What is the patient¿s current status? patient was very sick pre event.Required a full vs.Normal partial sternotomy post event for reoperation.Current status is unknown.Is the actual product involved in the reported issue and/or representative samples available to be returned for evaluation? device was not saved.The following information was requested but unavailable: name of index surgical procedure? unknown, but some type of open heart surgery.The diagnosis and indication for the index surgical procedure? product lot number? what instruments were used on the blunt needle/temporary pacing wire? how/where was the blunt needle being grasped? how/where was the temporary pacing wire being grasped? did the operating surgeon observe any product deficiency or anomaly before, during or after the placement? were there any precipitating factors to the metal tabs breaking off post-op? what is physician¿s opinion as to the etiology of or contributing factors to this event?.
Event or Problem Description
It was reported that an infant underwent an unknown open-heart procedure on (b)(6) 2021 and a temporary pacing wire was used.Two weeks post-op, with patient still in the hospital, the metal tabs broke off of the pacing wires requiring staff to do manual chest compressions till an external defibrillator was available to revive the patient.Due to complication of the pacing wires, the patient's scheduled pacemaker procedure was converted from partial to full sternotomy to insert pacemaker.No additional information was provided.

• Brand Name: TPW 2X24IN 2-0 D/A BB-1,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
• MDR Report Key: 13342867
• Report Number: 2210968-2022-00632
• Device Sequence Number: 4064467
• Product Code: LDF
• UDI-Device Identifier: 10705031050914
• UDI-Public: 10705031050914
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPW42
• Device Catalogue Number: TPW42
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Sex: Unknown
• Patient Weight: 4 KG