BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 2013671 · Received February 4, 2011

    Report

    Report Number
    2242352-2011-00018
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE SEAL HAD BEEN DEPLOYED AND UNRAVELED. THE TENSION SPRING ASSEMBLY WAS STILL INSIDE THE DELIVERY TUBE. THE WHITE COLLAR WAS NOT PRESENT AND THE PLUNGER HAS BEEN DEPRESSED. THE UNIT WAS VERY BLOODY. BASED UPON THESE FINDINGS, THE REPORTED FAILURE "SEAL DID NOT OPEN PROPERLY" COULD NOT BE CONFIRMED. 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 A CORONARY ARTERY BYPASS PROCEDURE, THE SEAL DIDN'T OPEN PROPERLY WHEN PLACING THE SEAL INTO THE AORTA. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING PROXIMAL SEAL, 4.5 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-1045 25019328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA