BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OVER-THE-WIRE PTCA CATHETER

    MDR report key: 1061939 · Received June 16, 2008

    Report

    Report Number
    2134265-2008-01684
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    PMA / PMN Number
    P8600169/162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, DIFFICULTY IN CATHETER REMOVAL OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE 99% STENOTIC, SEVERELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO ADVANCE THE 2.5 X 15 MM MAVERICK OVER THE WIRE BALLOON ALONG ANOTHER MFR'S GUIDE WIRE, HOWEVER, THE BALLOON BECAME STUCK AT THE ENTRANCE TO THE RCA. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE BALLOON, BUT EXPERIENCED DIFFICULTY WHILE TRYING TO REMOVE IT. THE PHYSICIAN THEN REMOVED THE MAVERICK BALLOON ALONG WITH THE GUIDEWIRE AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT FURTHER COMPLICATIONS AND THE PT CONDITION IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OVER-THE-WIRE PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORP. 15/2.5 9385292

    Patients

    Seq Age Sex Outcome Treatment
    1 BMW GUIDE WIRE