BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3761114 · Received April 21, 2014

    Report

    Report Number
    2134265-2014-02078
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 27, 2014
    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.: RETURNED PRODUCT CONSISTED OF AN NC QUANTUM BALLOON CATHETER. THE CATHETER WAS VISUALLY AND TACTILELY INSPECTED. THERE WAS BLOOD IN THE INFLATION LUMEN AND GUIDEWIRE LUMEN. THE DEVICE WAS RETURNED IN TWO (2) PIECES. THERE WERE MULTIPLE HYPOTUBE KINKS AND THE HYPOTUBE WAS BROKEN 42CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 30X4.0MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, AN UNSPECIFIED STENT WAS USED TO TREAT THE TARGET LESION. A 15MM X 4.0MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN SELECTED AND ADVANCED FOR POSTDILATION. THE SHAFT (ABOUT 40CM AWAY FROM THE HUB) WAS BROKEN OFF DURING PUSHING OF THE DEVICE. THE PHYSICIAN WITHDREW THE BALLOON TOGETHER WITH THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED, 30X4.0MM, ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, AN UNSPECIFIED STENT WAS USED TO TREAT THE TARGET LESION. A 15MM X 4.0MM QUANTUM MAVERICK BALLOON CATHETER WAS THEN SELECTED AND ADVANCED FOR POSTDILATION. THE SHAFT (ABOUT 40CM AWAY FROM THE HUB) WAS BROKEN OFF DURING PUSHING OF THE DEVICE. THE PHYSICIAN WITHDREW THE BALLOON TOGETHER WITH THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240457 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015400 16532173

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR