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 Low Blood Pressure/ Hypotension (1914)

Event Date 04/25/2021

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.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 an orthotopic cardiac allotransplantation procedure on (b)(6) 2021.It was reported that epicardial wire broke at the point where wire connects to post.Breakage occurred on (b)(6) 2021.The patient had drop in blood pressure and mild hemodynamic compromise.Physician assistant stripped the plastic coating off a portion of the wire and sutured the post against the bare wire and was able to regain pacing.New wires were placed during washout in or the next day.Additional information will be 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: 1.Did the operating surgeon observe any suture deficiency or anomaly before or during the placement?- abnormalities were not observed in the or during placement.2.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.3.What is the patient¿s current status? were symptoms resolved? - symptoms resolved, this information was already provided please see event description.The following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure? product lot number? 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.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? 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? are actual and/or representative samples available? if yes, return date, tracking information? 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: 11953345
• MDR Text Key: 262421765
• Report Number: 2210968-2021-05339
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention