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 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent additional information was obtained: change event description to the following: - it was reported that following a cardiac procedure, when the patient was brought to the icu, the cardiac pacing wire fractured at the juncture of the needle and the wire.Attempts are being made to clarify 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.Please provide procedure date? please provide event date ? please provide lot number? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a cardiac surgery on unknown date in 2021 and the temporary pacing wire was placed.It was reported that the cardiac pacing wire fractured at the juncture of the needle and the wire.This event occurred when the patient was brought to the icu.A new suture was used to complete the case with no patient consequences.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 09/01/2021.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Additional information was requested and the following was obtained: tpw32 was placed during a cardiac procedure.While patient was in icu the reported event occurred.The wire fractured at the junction of the needle and the wire.Staff used a scalpel to strip to reconnect to pacer cable.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: 09/13/2021 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested, and the following was obtained: 1.What instruments were used on the blunt needle/temporary pacing wire during/after placement? how/where is the blunt needle being grasped?- everything was going ok in or during tpw placement and needle breakaway process.During the needle breakaway, a needle holder/grasper was used to hold a part which coming off the needle to release a pin.Then an exposed pin part was taped/secured seems to the patient¿s body in order to move patient from or to icu.2.How/where is the temporary pacing wire being grasped?- they used hands on the wire side during needle breakaway process.3.Do you know if we should still expect another sample with needle breakaway piece? if yes, please specify under what pc number.¿sample which they planned to ship to us was already sent under different file.At this time, we do not have any other samples on hold or in the process of shipping.- it was reported that there are no problems during insertion.They usually use a stay suture where the wire exits the skin, plus tegaderm is used on top to secure.No intentional tension is placed on the wire.The hospital is seeing the suture is breaking near the swage days after insertion while still in the icu.They use kits prepackaged from distributor which makes it difficult to track the lot number.Distributor uses re-sterilization on their surgical packs.

• 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
• MDR Report Key: 12250842
• MDR Text Key: 264279239
• Report Number: 2210968-2021-06841
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1