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 07/24/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Component code: (b)(4) device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.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.What was the name of the procedure? what is the lot number?.

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and suture was used.Post-operatively, it was reported that the suture broke.Patient had tpw32 inserted on (b)(6) 2021.The patient was paced from 7/21-7/24.Required high ma on atrial side (18 ma).Pacer turned off and removed bridging cables.After hcp's inspected, they found pins a few hours later broken from tpw32 wires.Hcp's were able to discontinue pacing without any further need.Patient is recovering well.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 9/15/2021.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: note: event reported in 2210968-2021-07689 and 2210968-2021-08449.

Manufacturer Narrative

Pc(b)(4).Date sent to the fda: 9/13/2021 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 h3 investigation summary: four pieces of wire with insolation tangled product code tpw32 were returned to ethicon inc for analysis.In order to evaluate the conditions of the returned sample, the multifilament stainless steel coated with blue polyethylene were received tangled, body fluids could be noted, with damages within insolation (cutted) appear to be caused by a surgical instrument, and wires were noted to be exposed.As per ifu states that with any device, care should be taken to avoid damage to the strand when handling.The packet contains two wires (light blue and dark blue) with sh curved needle and a sks-3 straight cutting needle breakaway.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 "both the atrial and ventricular wires broke on this patient".Can you please confirm if 2 temporary pacing wires were used for this patient and broke?there are 2 wires per set.On the case below, it was both sets, atrial and ventricular that broke.- 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: 12367200
• MDR Text Key: 268132631
• Report Number: 2210968-2021-07689
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR