BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 2081876 · Received April 5, 2011

    Report

    Report Number
    2242352-2011-00228
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE TENSION SPRING ASSEMBLY WAS INSIDE THE DELIVERY TUBE. THE SEAL WAS EXTENDED OUTSIDE THE TUBE. THE SEAL HAD CRACKED ALONG THE SECOND RIM FROM THE EDGE. THE WHITE COLLAR WAS NOT PRESENT; THE PLUNGER HAD BEEN DEPRESSED. THE DEVICE WAS VERY BLOODY. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL CRACKED DURING USE" WAS 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 HEARTSTRING II SEAL CRACKED DURING USE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT 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 25010118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA