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 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been 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.(b)(4).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.Product lot number? did the operating surgeon observe any suture deficiency or anomaly before or during the placement? what was happening when the suture/wire breakage occurred? please specify.Was any medical or surgical intervention required due to the suture/wire post op breakage?.

Event Description

It was reported that a patient underwent a heart transplant procedure on (b)(6) 2021 and a temporary pacing wire was used.Post-op on (b)(6) 2021, site care was completed earlier in day and wires were intact.Later in day, the rn noticed the wire had broken.The v wire fractured at the pin connection site, color of wire unknown.The patient was connected to pacemaker box at time of breakage.There were no adverse consequences for the patient.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: 12075612
• MDR Text Key: 258646742
• Report Number: 2210968-2021-05859
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• 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