BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE¿ 26 ADVANTAGE KIT

    MDR report key: 2872990 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07594
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Removal / Correction Number
    90803893FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT COULD NOT BE REVIEWED. THE ROOT CAUSE FOR THIS COMPLAINT IS SUPPLIER DESIGN. INVESTIGATION OF THE ISSUE FOUND THAT THE VENDOR PROCESS FOR HUB TO CANNULA TRANSITION IS NOT OPTIMIZED TO PRODUCE THE INSERTION TOOL PART. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, THE GUIDEWIRE WAS DAMAGED. WHILE INSERTING A NON-BSC GUIDE WIRE IN THE INSERTION TOOL, THE GUIDE WIRE WAS "SHREDDED" AS IT PASSED THROUGH. THERE WAS A GRITTY FEEDBACK FROM THE WIRE AS IT PASSED. NO PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE¿ 26 ADVANTAGE KIT SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527052

    Patients

    Seq Age Sex Outcome Treatment
    1