BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPW 2X24IN 2-0 D/A SH,SKS-3 BWY

    MDR report key: 12250803 · Received July 30, 2021

    Report

    Report Number
    2210968-2021-06840
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 4, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LDF
    UDI-DI
    10705031050891
    PMA / PMN Number
    K980503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 8/25/2021. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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: H6. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: -WAS ANY MEDICAL/SURGICAL INTERVENTION REQUIRED DUE TO THE WIRE BREAKAGE AND LOSS CAPTURE OF CARDIAC RHYTHM? IF YES, PLEASE SPECIFY. YES, PA HAD TO STRIP THE WIRE TO RECONNECT. LOSS CAPTURE OF CARDIAC RHYTHM, HAD TO TRIAGE TO ISOLATE IT. OVERALL, NO TECHNIQUE CHANGE. -WAS THE INDEX PROCEDURE DATE 07/04/2021 WHEN TPW WAS PLACED? N/A. -LOT NUMBER? N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 09/13/2021. 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: 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.

    Additional Manufacturer Narrative · 1

    (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: DATE OF EVENT: (B)(6) 2021. EVENT DESCRIPTION: TPW32 IS PLACED DURING A CARDIAC PROCEDURE, BUT THE EVENT OCCURRED DURING POST-OP IN ICU. IT WAS REPORTED THAT ONE OF THE ARTERIAL PACING WIRES BROKE AT THE JUNCTION OF THE NEEDLE AND WIRE. AS A RESULT, PA HAD TO STRIP THE WIRE TO RECONNECT. LOSS CAPTURE OF CARDIAC RHYTHM, HAD TO TRIAGE TO ISOLATE IT. OVERALL, NO TECHNIQUE CHANGE. DATE OF EVENT: (B)(6) 2021. WHEN THE EVENT OCCURRED: POST-OP IN CICU. PATIENT AGE: (B)(6). PATIENT CONSEQUENCE: LOSS OF CARDIAC RHYTHM, CLINICAL STAFF HAD TO TRIAGE TO ISOLATE IT. ATTEMPTS ARE BEING MADE TO CLARIFY 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. WAS ANY MEDICAL/SURGICAL INTERVENTION REQUIRED DUE TO THE WIRE BREAKAGE AND LOSS CAPTURE OF CARDIAC RHYTHM? IF YES, PLEASE SPECIFY. WAS THE INDEX PROCEDURE DATE (B)(6) 2021 WHEN TPW WAS PLACED?. LOT NUMBER?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC SURGERY ON (B)(6) 2021 AND THE TEMPORARY PACING WIRE WAS PLACED. IT WAS REPORTED THAT ONE OF THE ARTERIAL PACING WIRES BROKE AT THE JUNCTION OF THE NEEDLE AND WIRE. THIS EVENT OCCURRED DURING POST-OP IN ICU ON (B)(6) 2021. OVERALL, THERE WAS NO TECHNIQUE CHANGE. AS A RESULT OF EVENT, PA HAD TO STRIP THE WIRE TO RECONNECT. THERE WAS LOSS CAPTURE OF CARDIAC RHYTHM AND CLINICAL STAFF HAD TO TRIAGE TO ISOLATE IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152458 TPW 2X24IN 2-0 D/A SH,SKS-3 BWY ELECTRODE, PACEMAKER, TEMP LDF ETHICON INC. TPW32 10705031050891

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO