BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2192989 · Received July 21, 2011

    Report

    Report Number
    2242352-2011-00987
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE CUTTER HAD NOT BEEN ACTUATED. WHEN THE GREEN CAP WAS REMOVED, IT WAS OBSERVED THAT THE NEEDLE WAS BENT. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "NEEDLE WAS BENT" WAS CONFIRMED BUT IT COULD NOT BE CONFIRMED THAT THE CUTTER WAS SHIPPED WITHOUT THE GREEN PROTECTIVE CAP ON. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III AORTIC CUTTER WAS SHIPPED WITHOUT PROTECTIVE CAP ON THE AORTIC PUNCH AND THE NEEDLE WAS BENT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25022246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA