BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 2013477 · Received February 3, 2011

    Report

    Report Number
    2242352-2011-00016
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 5, 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 DELIVERY TUBE HAD DETACHED. THE WHITE COLLAR WAS NOT PRESENT AND THE PLUNGER HAD BEEN DEPRESSED. THE SEAL WAS EXTENDING OUTSIDE THE DELIVERY TUBE AND IT WAS INTACT. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS, THE REPORTED FAILURE "DELIVERY TUBE CAME OFF" 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE DELIVERY TUBE CAME OFF. A REPLACEMENT UNIT 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 PROXIMAL SEAL, 4.5 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HS-1045 25010602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA