BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK HZ APPLIER MED 8" CVD

    MDR report key: 20978980 · Received December 19, 2024

    Report

    Report Number
    3011137372-2024-00192
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    November 13, 2024
    Report Date
    November 27, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "PER CUSTOMER PROVIDED INFORMATION THE DHR FOR THE ALLEGED DEFECTIVE MEDICAL DEVICE WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. THE ALLEGED DEFECTIVE INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA, WI FACILITY AS PART OF A (B)(4) PIECE LOT FROM JANUARY OF 2023. IT WAS FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS, AND ALL APPROVED PROCESSES WERE FOLLOWED. THIS INSTRUMENT HAS NOT BEEN RETURNED FOR REVIEW OR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE ALLEGED DEFECT OR VALIDATE THE ALLEGED COMPLAINT. ALL (B)(4) INSTRUMENTS FROM THIS LOT WERE 100% VISUALLY INSPECTED AND FUNCTION TESTED PRIOR TO SHIPMENT TO THE CUSTOMER AS THIS IS A STANDARDIZED PROCEDURE AT THIS FACILITY FOR THIS PRODUCT LINE. DUE TO THESE FINDINGS, NO FURTHER ACTIONS WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND THIS RECORD WILL BE DEEMED CLOSE." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CARDIAC SURGERY IN THE IMMEDIATE POSTOPERATIVE PERIOD, "THE PATIENT PRESENTED A PICTURE OF CARDIAC TAMPON ADE ATTRIBUTED TO DISLODGEMENT OF A TITANIUM CLIP. THIS SITUATION REQUIRED EMERGENCY SURGERY AND BLEEDING WAS FOUND AT THE LEVEL OF ONE OF THE CORONARY BRIDGES". A NEW CLIP WAS USED ALONGSIDE REINFORCEMENT WITH SILK TO ENSURE HEMOSTASIS. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CARDIAC SURGERY IN THE IMMEDIATE POSTOPERATIVE PERIOD, "THE PATIENT PRESENTED A PICTURE OF CARDIAC TAMPON ADE ATTRIBUTED TO DISLODGEMENT OF A TITANIUM CLIP. THIS SITUATION REQUIRED EMERGENCY SURGERY AND BLEEDING WAS FOUND AT THE LEVEL OF ONE OF THE CORONARY BRIDGES". A NEW CLIP WAS USED ALONGSIDE REINFORCEMENT WITH SILK TO ENSURE HEMOSTASIS. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099246 WECK HZ APPLIER MED 8" CVD APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL 06F2249483

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male