BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3841221 · Received May 30, 2014

    Report

    Report Number
    2134265-2014-02933
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH A NC QUANTUM APEX SHELF BOX. THE BATCH NUMBER ON THE RETURNED PACKAGING AND DEVICE MATCHED THE REPORTED BATCH NUMBER. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A COMPLETE HYPOTUBE FRACTURE 58CM FROM THE STRAIN RELIEF. THE HYPOTUBE FRACTURE SURFACES WERE OVAL, 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 DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE HYPOTUBE KINKS OR THE SEPARATED HYPOTUBE. 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. AN 8MM X 2.25MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION HOWEVER THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319574 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408220 16732335

    Patients

    Seq Age Sex Outcome Treatment
    1