MAUDE Adverse Event Report: ETHICON INC. TPW 24IN 2-0 D/A BB,SKS BWY; ELECTRODE, PACEMAKER, TEMP

Model Number TPW20

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

(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.Component code: g07002 device not returned.To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.The following information was requested but unavailable: did the wire disconnect from the pacer box? was an additional surgical procedure required for the reconnection of the pacing lead? was any medical or surgical intervention required for this event? were there any adverse patient consequences?.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and a temporary pacing wire was used.On the fifth day after the surgery, the connector of the temporary epicardial pacing lead was disconnected, so the connection was reconnected.There were no adverse patient consequences reported.No additional information could be provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/27/2023.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was received: after investigation, a 59-year-old male patient underwent coronary artery bypass grafting due to "coronary heart disease" on (b)(6) 2022.The operator used tpw20 for temporary cardiac pacing during the operation.The distal end of the temporary cardiac pacing lead was connected to the myocardium and the near end of the temporary cardiac pacing lead was connected to the temporary pacing/monitoring device (the hospital could not provide a specific connection device).The connection was smooth during the operation.No device failure or patient injury event was reported.On the 5th day after operation, the connection between the near end of temporary cardiac pacing wire was disconnected from the temporary pacing/monitoring device, so the doctor immediately reconnected the temporary cardiac pacing wire to the device.There was no harm to the patient due to this event, and the patient has been discharged smoothly now.No subsequent adverse events were reported.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 24IN 2-0 D/A BB,SKS BWY
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16328963
• MDR Text Key: 309165899
• Report Number: 2210968-2023-00932
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050877
• UDI-Public: 10705031050877
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW20
• Device Catalogue Number: TPW20
• Device Lot Number: RKBEBC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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 Age: 59 YR
• Patient Sex: Male