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 Arrhythmia (1721)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to receive a device.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.Attempts are being made to obtain/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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? product lot number? did the operating surgeon observe any suture deficiency or anomaly before or during the placement? when was the wire breakage observed? were there any patient consequences due to wire breakage? if yes: please specify symptoms.Was there any medical/surgical intervention required to treat symptoms? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? were symptoms resolved if any? are actual and/or representative samples available? if yes, return date, tracking information? additional information was requested, and the following was obtained: what is the procedure name? aortic valve replacement, mechanical.What is the procedure date? (b)(6) 2020.Quantity of devices involved in each procedure: one wire failed.Unknown whether it was the dark or light blue wire.Event description stating when each involved device had a wire breakage issue in the procedure.Temporary epicardial wires noted not to capture before externalized permanent (¿temporary permanent¿) pacemaker placed on (b)(6) 2020.Wires removed (b)(6)2021 when breakage noted at the juncture between the wire and the post.Any adverse patient consequences and how were they managed? hemodynamic compromise due to junctional escape rhythm.Externalized temporary pacemaker placed on (b)(6) 2020.Please provide the status of the device(s) as it has not been received for analysis.Do not have the wire; wire was not retained.

Event Description

It was reported that the patient underwent an aortic valve replacement/mechanical procedure on (b)(6) 2020 and the temporary pacing wire was used.Temporary epicardial wires noted not to capture before externalized permanent/ "temporary permanent" pacemaker placed on (b)(6) 2020.The patient experienced hemodynamic compromise due to junctional escape rhythm and externalized temporary pacemaker placed on (b)(6) 2020.Wires removed on (b)(6) 2021 when breakage noted at the juncture between the wire and the post.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 06/23/2021.Additional h6 component code: g07002 ¿ device not returned.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 requested, and the following was obtained: did the operating surgeon observe any suture deficiency or anomaly before or during the placement?- abnormalities were not observed in the or during placement what is physician¿s opinion as to the etiology of or contributing factors to this event? - the physicians do not know why the product is failing were there any patient consequences due to wire breakage? if yes: please specify symptoms.Was there any medical/surgical intervention required to treat symptoms? - please see event description for information, that is all that was provided.The following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure? product lot number? when was the wire breakage observed? what is the patient¿s current status? were symptoms resolved? 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.

• 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: 11980378
• MDR Text Key: 264318326
• Report Number: 2210968-2021-05453
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/10/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/23/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention