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 Cardiac Arrest (1762)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 obtained: change event description: - cardiac pacing wire was implanted on 6/28 at the end of an avr procedure.Following the surgery, the patient was brought to cicu at the same facility, where the event occurred on 6/30.It was reported that the cardiac pacing wire fractured at the junction of the needle and the wire.Following the event, it was discovered that at some point the arterial wire cracked.No technique changes by icu staff.Event date: 6/30/2021 when the event occurred: - post-op in cicu did the patient experience a post-op device malfunction? - yes.If yes, please describe: - had to unplug the pacemaker.Discovered after event occurred, that at some point the arterial wire cracked at some point.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? - yes, patient had an r on t event, patient went into cardiac arrest (2) times.Patient received acls.Patient ended up on va ecmo.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? - yes, patient received acls and ended up on va ecmo.Patient outcome: patient ended up on va ecmo.Patient consequence/ medical intervention: patient's pacemaker had to be unplugged.Patient had an r on t event, went into cardiac arrest (2) times and had to receive acls.No samples.

Event Description

It was reported that the patient underwent an avr procedure on (b)(6) 2021 and the temporary pacing wire was implanted at the end of surgery.Following the surgery, the patient was brought to cicu at the same facility, where the event occurred on (b)(6) 2021.It was reported that the cardiac pacing wire fractured at the junction of the needle and the wire connection.No technique changes were done by icu staff.It was discovered after event occurred, that at some point the arterial wire cracked.The patient¿s pacemaker had to be unplugged.The patient experienced an r on t event and went into cardiac arrest twice.The patient received acls and ended up on va ecmo.Additional information will be requested.

Manufacturer Narrative

Date sent to the fda: 09/09/2021.Additional information was requested, and the following was obtained: 1.What instruments were used on the blunt needle/temporary pacing wire during/after placement? how/where is the blunt needle being grasped?- everything was going ok in or during tpw placement and needle breakaway process.During the needle breakaway, a needle holder/grasper was used to hold a part which coming off the needle to release a pin.Then an exposed pin part was taped/secured seems to the patient¿s body in order to move patient from or to icu.2.How/where is the temporary pacing wire being grasped?- they used hands on the wire side during needle breakaway process.3.Do you know if we should still expect another sample with needle breakaway piece? if yes, please specify under what pc number.¿sample which they planned to ship to us was already sent under different file.At this time, we do not have any other samples on hold or in the process of shipping.- it was reported that there are no problems during insertion.They usually use a stay suture where the wire exits the skin, plus tegaderm is used on top to secure.No intentional tension is placed on the wire.The hospital is seeing the suture is breaking near the swage days after insertion while still in the icu.They use kits prepackaged from distributor which makes it difficult to track the lot number.Distributor uses re-sterilization on their surgical packs.The following information was requested, but unavailable: the patient demographic info: weight, bmi at the time of index procedure? did the operating surgeon observe any product deficiency or anomaly before, during or after the placement? other relevant patient comorbidities/patient factors/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? is the actual product involved in the reported issue available to be returned for evaluation? what is the patient¿s current status? 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: 08/20/2021.Attempts are being made to receive additional 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: weight, bmi at the time of index procedure? did the operating surgeon observe any product deficiency or anomaly before, during or after the placement? other relevant patient comorbidities/patient factors/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? is the actual product involved in the reported issue available to be returned for evaluation? what is the patient¿s current status? product lot number? what instruments are used on the blunt needle/temporary pacing wire? how/where is the blunt needle being grasped? how/where is the temporary pacing wire being grasped? 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: 12242459
• MDR Text Key: 264061081
• Report Number: 2210968-2021-06791
• 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: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 09/01/2021
• Supplement Dates FDA Received: 08/20/2021; 09/09/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR