BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18596032 · Received January 29, 2024

    Report

    Report Number
    2210968-2024-00719
    Event Type
    Malfunction
    Date Received
    January 29, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LDF
    UDI-DI
    10705031050891
    PMA / PMN Number
    K980503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? NOT AVAILABLE. WERE THERE ANY PATIENT CONSEQUENCES? IF YES, PLEASE PROVIDE MORE DETAILS. INQUIRED, UNKNOWN AT THIS TIME. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THE PATIENT CONSEQUENCES (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. INQUIRED, NO INFORMATION AVAILABLE AT THIS TIME. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. UNKNOWN PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. SITE HAS NOT YET RELEASED DEVICE. TBD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, TPW32 PACING WIRE NOT FUNCTIONING- UPON ATTEMPTED REMOVAL BY NURSE WIRE BROKE, ONLY PARTIALLY CAME OUT. SEE REPORT. IMAGE ATTACHED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848759 TPW 2X24IN 2-0 D/A SH,SKS-3 BWY ELECTRODE, PACEMAKER, TEMP LDF ETHICON INC. 10705031050891

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown