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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(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.(b)(4).Additional information was requested and the following was obtained: did the suture/wire breakage occur post-op? yes.Date of event/suture breakage? multiple.Please see previous document.What was happening when the suture breakage occurred? please specify.Multiple situations.Patient movement, standard cares, day to day activities.It was stated that the procedure is a coronary artery bypass graft x2, mitral valve repair.What is meant by the ¿x2¿? two vessels were bypassed.Please provide lot number? multiple lots likely involved.One lot number was provided previously.Could you please provide details on the patient consequences due to this event? this was already provided in the previous document.Can you please clarify if any medical/surgical intervention was performed for the suture breakage post-op? please specify details and date of any intervention? other patient co-morbidities? all of these details were provided on the previous document.Are actual and/or representative samples available? these have been sent.I have two more in my office since the previous batch was sent.Any photos available of the suture breakage? no answer provided.What was the indication for cardiac surgery on (b)(6) 2021? coronary artery bypass graft, mitral valve repair.The surgery took place on (b)(6) 2020.The patient died on (b)(6) 2021.Please clarify if there was any relation to the patient¿s death on (b)(6) 2021 from other sequelae of cardiac surgery was related to the event of suture breakage post-op.Unrelated.Could you please clarify what is meant by ¿other specified retained foreign body fragments¿ with ¿av epicardial pacing wires s/p cvs¿ and how does this relate to the event.I will follow up with the nurse practitioner who left this note.I'm unsure.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.It was previously stated that samples have been sent and that you have two more in your office since the previous batch was sent.Were these other 2 samples opened/used? are you planning on sending them back?.

Event Description

It was reported that a patient underwent a coronary artery bypass graft with 2 vessels bypassed and a mitral valve repair on (b)(6) 2020 and a temporary pacing wire was used.Post-op, one wire was noted to be fractured, unknown if it was the light blue or dark blue wire.The patient died of other sequelae of cardiac surgery on (b)(6) 2021.It was reported that the patient¿s death was unrelated to the post-op suture breakage.There were no adverse patient consequences reported from the post-op suture breakage.No additional information was provided.

• 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
• MDR Report Key: 12075681
• MDR Text Key: 270341344
• Report Number: 2210968-2021-05852
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1