BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 2021980 · Received March 17, 2011

    Report

    Report Number
    2134265-2011-00944
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE BALLOON CATHETER WAS RETURNED IN A DEFLATED STATE. THE BALLOON WAS INSPECTED UNDER MAGNIFICATION TO LOCATE THE BALLOON DEFECT. A LONGITUDINAL TEAR WAS CONFIRMED IN THE BALLOON WALL LOCATED ON THE DISTAL PORTION OF THE BALLOON MEASURING 2.5MM IN LENGTH . MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL WHICH WOULD HAVE CONTRIBUTED TO THE TEAR. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-00782. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 60% STENOSED, 4.0X16MM ECCENTRIC AND DENOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY (LM). A 1.5X15MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, IT RUPTURED AT AN UNKNOWN PRESSURE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 2.25X12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION. WHILE USING THE DEVICE IT WAS NOTED THAT THE BALLOON WAS "BROKEN". THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-00782. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 60% STENOSED, 4.0X16MM ECCENTRIC AND DENOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN ARTERY (LM). A 1.5X15MM MAVERICK2 BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, IT RUPTURED AT AN UNKNOWN PRESSURE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THEN A 2.25X12MM QUANTUM MAVERICK BALLOON CATHETER WAS ADVANCED TO THE LESION. WHILE USING THE DEVICE IT WAS NOTED THAT THE BALLOON WAS 'BROKEN'. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012220 13444937

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR JL GUIDE CATHETER| BMW GUIDE WIRE| 1.5X15MM MAVERICK2 BALLOON CATHETER