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 Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain 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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the tissue condition (normal, thin, calcified, fragile, diseased)? when did the bleeding occur? what was the source and triggering event of bleeding? what was the volume of blood loss? how was the bleeding treated? were there any deficiencies or anomalies noted with the device prior to, during or after the procedure? upon removal of the wire, were any deficiencies or anomalies noted with the wire? please describe any medical/surgical intervention required for this suture event including dates and results.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 patient's current status? lot number? if applicable, will product be returned? if so, please provide the return date and tracking information.Is this a teaching hospital? who is placing the temporary pacing wire? is a resident placing the temporary pacing wire? related medwatch reports: 2210968-2022-05800, 2210968-2022-05801, 2210968-2022-05802 and 2210968-2022-05804.

Event Description

It was reported that a patient underwent a temporary pacing wire placement procedure on an unknown date.The surgeon stated they recently switched to this kind of temporary pacing wires.The patient experienced delayed tamponade, presumably related to removal of the wire.While obviously it is difficult to know for certain if the leads are the cause, the onset of a previously rare event coinciding with the adoption of the new leads cannot be ignored.The pacer wire was removed four or five days following surgery while the patient is on the ward and just prior to discharge home.The patient had bleeding the day following removal of the wires.The bleeding is caused by bleeding from epicardial vessels on the heart related to trauma from removing the pacer wire.The bleeding is contained within the pericardial spacing and caused tamponade necessitating a take back for bleeding.Additional information was requested.

• 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: 15086105
• MDR Text Key: 296407988
• Report Number: 2210968-2022-05803
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• 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
• Date Manufacturer Received: 07/04/2022
• 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): Required Intervention