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 Type  malfunction  

Manufacturer Narrative

(b)(4).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 patients 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.(b)(4).

Event 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
• 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: 12287868
• MDR Text Key: 265392355
• Report Number: 2210968-2021-07069
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1