MAUDE Adverse Event Report: ETHICON INC. TEMP PACING WIRE 24"(60CM) 2-0 LT/DK BLU; ELECTRODE, PACEMAKER, TEMP

Catalog Number TPW32

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2019.During the procedure the needle broke in half when passing through tissue.The piece did fall into the patient and the piece was recovered.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record review was performed for the finished device lot and no non-conformances were identified.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 LT/DK BLU
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8478995
• MDR Text Key: 141208414
• Report Number: 2210968-2019-79966
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (y/n): N
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: TPW32
• Device Lot Number: MHH439
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Patient Sequence Number: 1