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 Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested, and the following was obtained: what is the total number of procedures? i don¿t fully understand this question.We perform 6-8 cardiac surgery cases per day and epicardial wires are placed in nearly all of these cases.I don¿t have more detailed information immediately at hand.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.If this event occurred in multiple procedures, please provide the following information for each patient event: i will need to do some digging to get this information.I can get back to you.What is the procedure name? what is the procedure date? quantity of devices involved in each procedure? event description stating when each involved device had a wire breakage issue in the procedure.Any adverse patient consequences and how were they managed? 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Date sent to the fda: 06/10/2021.A manufacturing record evaluation was performed for the finished device batch qjbdqk, tpw3244 and no non-conformances were identified.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? did the operating surgeon observe any suture deficiency or anomaly before or during the placement? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? 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? - orthotopic cardiac allotransplantation.- what is the procedure date? - (b)(6) 2021.- quantity of devices involved: - single wire noted to have fractured.Unknown whether light blue or dark blue wire.- event description : - epicardial pacing wires noted to be non-functioning in operative note on (b)(6) and were replaced during subsequent washout.- any adverse patient consequences and how were they managed? - patient had underlying junctional escape rhythm that was hemodynamically sufficient.Planned return to or for washout and ecmo drawdown trial allowed for new wires to be placed.- please provide the status of the device(s) as it has not been received for analysis.- these wires were not retained.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.Date sent to the fda: 06/10/2021 corrected information: b1, b2, h1- ¿¿upon additional information review, this device met serious injury reportability criteria.As a result, this medwatch report 2210968-2021-04870 has been updated from malfunction to serious injury.Corrected h-6 health effect - clinical codes: e0601 corrected h-6 health effect - impact codes: f19.Corrected b5 narrative: it was reported that the patient underwent an orthotopic cardiac allotransplantation procedure on (b)(6) 2021 and the temporary pacing wire was used.Epicardial pacing wires noted to be non-functioning in operative note on (b)(6) 2021 and were replaced during subsequent washout.It was reported that single wire noted to be fractured.Additional information has been requested.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.

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: the patient demographic info: age, gender, weight, bmi at the time of index procedure? - not allowed to provide patient identifiers.Did the operating surgeon observe any suture deficiency or anomaly before or during the placement? - no.What is physician¿s opinion as to the etiology of or contributing factors to this event? - they do not know why they are failing.The following information was requested, but unavailable: what is the patient¿s current status? 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: 11866759
• MDR Text Key: 267628414
• Report Number: 2210968-2021-04870
• 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,Followup
• Report Date: 04/26/2021

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
• Device Lot Number: QJBDQK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 06/11/2021
• Supplement Dates FDA Received: 06/10/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention