BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL 4.3MM

    MDR report key: 1931077 · Received November 11, 2010

    Report

    Report Number
    2242352-2010-03297
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE UNIT WAS RECEIVED WITH THE TENSION SPRING ASSEMBLY INSIDE THE DEPLOYMENT TUBE AND THE SEAL HANGING OUTSIDE THE TUBE. THE SEAL WAS PARTIALLY ROLLED AND HAD STARTED TO UNRAVEL. THE WHITE COLLAR WAS NOT PRESENT AND THE PLUNGER HAD BEEN DEPRESSED. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL WOULD NOT COME OUT OF DELIVERY DEVICE" COULD NOT BE CONFIRMED AS SEAL WAS OUTSIDE THE DEPLOYMENT TUBE. 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 HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL WOULD NOT COME OUT OF THE DELIVERY TUBE. THE EVENT REPORTEDLY OCCURRED IN (B)(6) 2010. THE STAFF IN THE HOSP ALWAYS GATHERS SOME DEFECTIVE PARTS UNTIL REPORTING THE FAILURE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL 4.3MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HS-1045 25012543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA