BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3564102 · Received January 9, 2014

    Report

    Report Number
    2134265-2013-09508
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE NC QUANTUM APEX DEVICE WAS RECEIVED WITH A SHELF BOX. THE BATCH NUMBER ON THE SHELF BOX AND DEVICE MATCHED THE REPORTED BATCH. THERE WAS BLOOD BETWEEN THE FOLDS OF THE BALLOON. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE MULTIPLE HYPOTUBE KINKS. THE HYPOTUBE WAS FRACTURED 85.5CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 8MMX 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS TAKEN OUT OF THE HOOP AND A KINK WAS NOTED AT THE SHAFT WHILE PUTTING IT ON THE WIRE. WHEN THEY TRIED TO LOAD IT ON THE WIRE, THE CATHETER SHAFT BROKE IN HALF. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT CONDITION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 8MMX 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS TAKEN OUT OF THE HOOP AND A KINK WAS NOTED AT THE SHAFT WHILE PUTTING IT ON THE WIRE. WHEN THEY TRIED TO LOAD IT ON THE WIRE, THE CATHETER SHAFT BROKE IN HALF. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT CONDITION WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16556 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408350 16518283

    Patients

    Seq Age Sex Outcome Treatment
    1