BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 2033652 · Received February 11, 2011

    Report

    Report Number
    2242352-2011-00048
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 14, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT "SEAL DID NOT DEPLOY PROPERLY" COULD NOT BE CONFIRMED. THE CONDITION OF THE RETURNED UNIT DOES NOT MATCH THE REPORTED COMPLAINT DESCRIPTION. THE FAILURE APPEARS TO BE "A FAILURE TO LOAD PROPERLY" BUT THE REPORTER HAS NOT CONFIRMED THAT. BASED ON THESE OBSERVATIONS, THE COMPLAINT WILL NOT BE CONFIRMED FOR "DEPLOYMENT FAILURE" BUT WILL BE CONFIRMED FOR "FAILURE TO LOAD PROPERLY." 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 III SEAL DID NOT DEPLOY PROPERLY. IT WAS REPORTED, "THERE WAS NO PROBLEMS WITH PREP AND DEPLOYMENT OF PROXIMAL SEAL WITHIN THE AORTOTOMY. THE PROBLEM OCCURRED WHEN REMOVING THE DELIVERY TUBE FROM THE AORTOTOMY. THE SEAL UNRAVELLED AS IT WAS CAUGHT ON THE DELIVERY TUBE." 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 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25020282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA