BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BX SONIC 3.50 X 23 MM

    MDR report key: 1230404 · Received November 7, 2008

    Report

    Report Number
    9616099-2008-02611
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE (WHICH IS INDICATED). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE DEPLOYMENT, THE HYPO TUBE OF THE SHAFT BROKE AT THE HUB AND SEPARATED. THE PATIENT WAS A MALE. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE VESSEL WAS DESCRIBED AS CALCIFIED AND TORTUOUS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED PRIOR TO USE AND NO ANOMALIES WERE FOUND. DURING DEPLOYMENT, THE HYPO TUBE SHAFT BROKE AND SEPARATED AT THE HUB. IT WAS NOTED THAT THERE WAS NO EXCESSIVE TORQUING WHILE ATTEMPTING TO DELIVER THE STENT. THE STENT WAS NOT TO BE DEPLOYED. THE PHYSICIAN REMOVED THE SHAFT OF THE DELIVERY SYSTEM FROM THE PATIENT AND ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC 3.50 X 23 MM CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA 13403338

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR