BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1213720 · Received October 22, 2008

    Report

    Report Number
    2134265-2008-03100
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT AN ANALYSIS OF THE COMPLAINT DEVICE, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED DAMAGE AND INSPECT THE DEVICE FOR POSSIBLE ROOT CAUSES. AS THE BATCH NUMBER IS UNK, A REVIEW OF THE MFG RECORD COULD NOT BE CARRIED OUT. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE BALLOON BECAME STUCK ON A STENT. A 90% STENOSED, CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING DEPLOYMENT OF ANOTHER MFR'S STENT, THE QUANTUM MAVERICK MR BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. RESISTANCE WAS MET AND THE BALLOON CATHETER COULD NOT PASS THROUGH THE STENT. PER IVUS IMAGING, THE BALLOON WAS CAUGHT ON A STENT STRUT. THE PHYSICIAN HAD COMMENTED THAT A PART OF THE STENT WAS RAISED. THE QUANTUM MAVERICK BALLOON WAS REMOVED FROM THE PT WITHOUT DIFFICULTY. POST DILATION WAS THEN PERFORMED WITH ANOTHER BALLOON SUCCESSFULLY. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS 'NO PROBLEM'. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X3.75 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVER STENT