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 Atrial Fibrillation (1729); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

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 a cardiovascular procedure in 2021 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: 06/23/2021.A manufacturing record evaluation was performed for the finished device batch qjbdqk, tpw3244 and no non-conformances were identified.Additional information was requested, and the following was obtained: 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.Are actual and/or representative samples available? if yes, return date, tracking information? defective products were returned please refer to your shipping information.The following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure? 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.

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? aortic valve replacement, tissue valve; mitral valve repair; tricuspid valve repair; left atrial appendage ligation.What is the procedure date? (b)(6) 2021.Quantity of devices involved- dark blue wire fractured at the point where the wire terminates in the post.Event description: patient was in bed waiting for permanent pacemaker placement.Wire broke at the point where wire terminates in metal post.Breakage occurred on (b)(6) 2021.Any adverse patient consequences and how were they managed? patient¿s underlying rhythm was atrial fibrillation in the 40¿s; patient was light-headed.Blood pressure remained stable.Nurse practitioner called heart rhythm service and notified them of the incident, heart rhythm service moved up this patient¿s procedure and was able to implant permanent device 30 minutes after wire fracture occurred.Please provide the status of the device(s) as it has not been received for analysis.I have this wire and the harness in my possession.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 upon additional information review, this device met serious injury reportability criteria.As a result, this medwatch report 2210968-2021-04872 has been updated from malfunction to serious injury.Clinical codes: e060102 impact codes: f19 corrected b5 narrative: it was reported that the patient underwent an aortic valve replacement, tissue valve; mitral valve repair; tricuspid valve repair and left atrial appendage ligation procedure on (b)(6) 2021 and the temporary pacing wire was placed.It was reported that the patient was in bed waiting for permanent pacemaker placement when wire broke/fractured at the point where wire terminates in the metal post.This breakage occurred on (b)(6) 2021.The patient¿s underlying rhythm was atrial fibrillation in the 40¿s.The patient was light-headed.Blood pressure remained stable.The heart rhythm service was notified about incident.They moved up this patient¿s procedure and was able to implant permanent device 30 minutes after wire fracture occurred.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: 07/1/2021.A manufacturing record evaluation was performed for the finished device batch qjbdqk, tpw3244 and no non-conformances were identified.Additional h-3 summary: multiples dark blue and light blue wire of product code tpw3244 were returned for analysis.In order to evaluate the conditions of the returned sample, the swage area and hole of the needle were noted with marks that appears to be by surgical instrument and the hole was observed with suture remnant.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.During the visual inspection of the suture¿s pieces body fluids, tissues, knots were noted.Also, the ends were cut and marks on the surface due to use were found, the end was cut by sharp edge.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Functional test was not performed, due to needle was received detached from suture.The condition of the sample received indicates improper handling of the device.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: 07/1/2021.

• 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: 11866758
• MDR Text Key: 253056149
• Report Number: 2210968-2021-04872
• 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,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention