BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3850954 · Received February 12, 2014

    Report

    Report Number
    2242352-2014-00098
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 20, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY WAS INSIDE THE DELIVERY DEVICE. THE SEAL AND THE ANCHOR TAB WERE EXTENDED OUTSIDE THE DELIVERY DEVICE. THE BLUE SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. IT APPEARS THAT THE SEAL HAD BEEN PREMATURELY DEPLOYED. AS STATED IN THE IFU, THE USER SHOULD ENSURE THAT THE LOCK IS LOCKED. IF THE LOCK IS UNLOCKED, CARE SHOULD BE TAKEN TO AVOID ANY ACCIDENTAL DEPRESSING OF THE PLUNGER. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93987 HS III PROXIMAL SEAL ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25089002

    Patients

    Seq Age Sex Outcome Treatment
    1 NI