BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3123554 · Received May 22, 2013

    Report

    Report Number
    2134265-2013-03266
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    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

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER. THERE WAS BLOOD IN THE GUIDEWIRE AND BETWEEN THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE MULTIPLE SHAFT KINKS. THERE WAS A HYPOTUBE SEPARATION 69.5CM FROM THE EDGE OF THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED 12MM X 3.0MM QUANTUM MAVERICK BALLOON CATHETER AND WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT SHAFT HAD FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED.THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE PHYSICIAN ADVANCED 12MM X 3.0MM QUANTUM MAVERICK BALLOON CATHETER AND WAS NOT ABLE TO CROSS THE LESION. UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT SHAFT HAD FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225754 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808012300 15406470

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR