BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP APPLIER MED 8" CVD

    MDR report key: 12829616 · Received November 17, 2021

    Report

    Report Number
    3011137372-2021-00316
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 23, 2021
    Report Date
    November 9, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    UDI-DI
    24026704696448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DHR FOR THE RETURNED INSTRUMENT WAS REVIEWED AND FOUND COMPLETELY WITHOUT ANY IRREGULARITIES. THIS INSTRUMENT WAS PRODUCED AT THE TECOMET, INC. KENOSHA WI FACILITY AS PART OF A 50-PIECE LOT IN OCTOBER OF 2017. EVALUATION OF THE RETURNED INSTRUMENT SHOWS THAT THE TIPS ARE SLIGHTLY MISALIGNED IN THE CLOSED POSITION. ALTHOUGH THE TIPS ARE SLIGHTLY MISALIGNED IN THE CLOSED POSITION FUNCTIONAL TESTING SHOWS THAT THIS INSTRUMENT IS ABLE TO PICK-UP , RETAIN, CLOSE AND RELEASE MULTIPLE CLIPS. 8 CLOSED CLIPS WHERE MEASURED AS THEY WERE AT TIME OF PRODUCTION AND ALL 8 CLIPS MEASURED TO HEMOCLIP PLUS APPLIER SPECIFICATIONS OF .0078" MAX. LEG GAP AT (.0041"-.0049") AND .0061" MAX. EYE GAP AT (.0019"-.0035") WE ARE UNABLE TO DETERMINE WHAT CAUSED THE TIPS TO BE SLIGHTLY MISALIGNED BUT MISHANDLING AT THE END USER'S FACILITY IS SUSPECTED. WE ARE ALSO UNABLE TO DETERMINE WHAT CAUSED THE ALLEGED DEFECT AT THE END USER'S FACILITY SINCE ALL THE LEG AND EYE GAPS OF THE CLIPS CLOSED DURING OUR TESTING MEASURED WITHIN FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    7 LIGACLIPS FALLING OFF THE SAPHENOUS VEIN, 2 FROM SIDE BRANCH ON A GRAFTED CORONARY ARTERY, 5 FROM THE LIGHTED END OF THE SAPHENOUS VEIN IN THE DONAU LEG. LIGATION CLIP APPLICATOR IDENTIFIED AND TESTED AND REMOVED FROM CIRCULATION AFTER CONCERNS IDENTIFIED. CLINICAL INCIDENT RAISED AND SERIOUS INVESTIGATION PROCESS COMMENCED AT HOSPITAL. CLINICAL CONSEQUENCES: PEA CARDIAC ARREST WITH EMERGENCY RESTERNOTOMY ON ITU AND ARREST OF BLEEDING FROM BLEEDING SIDE BRANCH OF SAPHENOUS VEIN GRAFT TO CORONARY ARTERY. HAEMATOMA OF DONOR LEG SITE.

    Description of Event or Problem · 0

    7 LIGACLIPS FALLING OFF THE SAPHENOUS VEIN, 2 FROM SIDE BRANCH ON A GRAFTED CORONARY ARTERY, 5 FROM THE LIGHTED END OF THE SAPHENOUS VEIN IN THE DONAU LEG. LIGATION CLIP APPLICATOR IDENTIFIED AND TESTED AND REMOVED FROM CIRCULATION AFTER CONCERNS IDENTIFIED. CLINICAL INCIDENT RAISED AND SERIOUS INVESTIGATION PROCESS COMMENCED AT HOSPITAL. CLINICAL CONSEQUENCES: PEA CARDIAC ARREST WITH EMERGENCY RESTERNOTOMY ON ITU AND ARREST OF BLEEDING FROM BLEEDING SIDE BRANCH OF SAPHENOUS VEIN GRAFT TO CORONARY ARTERY. HEMATOMA OF DONOR LEG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726110 HP APPLIER MED 8" CVD APPLIER, SURGICAL, CLIP GDO TELEFLEX MEDICAL IPN008881 06K1642042 24026704696448

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| L