BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM (TM) MAVERICK (TM)

    MDR report key: 2180583 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03087
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE QUANTUM MAVERICK MONORAIL BALLOON CATHETER WAS RECEIVED FOR ANALYSIS. THERE WAS CONTRAST IN THE INFLATION LUMEN. VISUAL INSPECTION OF THE BALLOON REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL MATERIAL MEASURING 14MM LONG. THE TEAR STARTED ON THE DISTAL END OF THE BALLOON AND EXTENDED MOST OF THE LENGTH OF THE BALLOON. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING RECORD CONFIRMED THAT 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE DE-NOVO, LESS THEN TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0X26 NON-BSC STENT WAS SUCCESSFULLY IMPLANTED. THE 30MM X 4.0MM QUANTUM MAVERICK MONORAIL BALLOON USED FOR POST DILATION WAS ADVANCED TO THE TARGET LESION. THE BALLOON CAME IN CONTACT WITH A STENT STRUT AND RUPTURED AT 20ATMS ON THE INITIAL INFLATION. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE DE-NOVO, LESS THEN TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.0X26 NON-BSC STENT WAS SUCCESSFULLY IMPLANTED. THE 30MM X 4.0MM QUANTUM MAVERICK MONORAIL BALLOON USED FOR POST DILATION WAS ADVANCED TO THE TARGET LESION. THE BALLOON CAME IN CONTACT WITH A STENT STRUT AND RUPTURED AT 20ATMS ON THE INITIAL INFLATION. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM (TM) MAVERICK (TM) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808030400 0013274735

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR STENT: RESOLUTE 4.0 X 26