BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 4.3 MM

    MDR report key: 1935852 · Received December 3, 2010

    Report

    Report Number
    2242352-2010-03520
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED WITHOUT THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY AND THE SEAL WERE RETURNED SEPARATE. THE SEAL WAS INTACT. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THE DEVICE WAS VERY BLOODY. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL FELL APART WHEN PULLING OUT OF AORTA" WAS CONFIRMED. THE COMPLAINT WAS INTERPRETED AS "SEAL DID NOT DEPLOY PROPERLY". A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. 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 A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL FELL APART UPON PULLING IT OUT OF THE AORTA. IT DID NOT OPEN UP CORRECTLY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM, 4.3 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25015050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA