BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3983072 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04487
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 9, 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

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON AND BLOOD BETWEEN THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A COMPLETE HYPOTUBE FRACTURE 79.5CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WERE MULTIPLE KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. 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 OR REPORTED CROSSING DIFFICULTY. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED AND SHAFT KINK OCCURRED. THE 100% STENOSED, 8X3.5 MM, ECCENTRIC AND DE NOVO TARGET LESION CONTAINING A <=45 DEGREES LESION BEND WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A 3.5MM X 8MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER WAS SELECTED FOR POSTDILATION BUT WAS UNABLE TO CROSS. IT WAS THEN NOTICED THAT THE SHAFT GOT KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461588 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808008350 16567941

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR