MAUDE Adverse Event Report: ETHICON INC. TPW 2X24IN 2-0 D/A SH,SKS-3 BWY; ELECTRODE, PACEMAKER, TEMP

Model Number TPW32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ventricular Fibrillation (2130)

Event Date 09/30/2022

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).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.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.Additional information was requested, and the following was obtained: the following information was requested, but unavailable: the single complaint was reported with multiple events.There are no additional details regarding the additional events.

Event Description

It was reported that a patient underwent a valve replacement procedure on an unknown date and a temporary pacing wire was inserted.Post-operatively, the patient was in sinus rhythm the entire time, all was well when he came out of the icu, with all the right settings.On the ward, it was not sensing the right rhythm and was pacing inappropriately which lead to his r on t and then to vf and to his death.The patient passed due to unrecognized r on t.Upon opening and inspecting the wires, they did not look defective or that there was anything wrong with them.The surgeon also added that even at the most sensitive setting of the device, it's not sensing properly.She also expressed some words on telemetry readings: "competence in the telemetry reading by the nurses or failure to do proper telemetry reading, where they weren't able to pick up the alert signal." additional notes from the surgeon: "i find the ethicon wires to be rough, the edges are rough and they fray.But because there is an impression amongst the surgeon group that the ethicon wires cause increased bleeding, we need to look at everything." thereafter, she also stated: "because the surgeon group has an impression that the pacing wire cause more bleeding, they were not attaching the wire too deep." additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/15/2022.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 was requested, and the following was obtained: lot number? unable to obtain as the product and packaged were not available/ discarded if applicable, will product be returned? no, it is not available.If so, please provide the return date and tracking information.Would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? yes ¿ still trying to obtain a meeting date with the surgeon.The following information was requested but unavailable: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date of index surgical procedure? the diagnosis and indication for the index surgical procedure? were the wires placed according to the ifu? how deep were the wires placed? date of death? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention performed for the vf event.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the surgeon¿s experience with the temporary pacing wires? were there any precipitating factors that could have caused the temporary pacing wire to move out of place?.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15640627
• MDR Text Key: 302098213
• Report Number: 2210968-2022-08600
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention