BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3203811 · Received July 3, 2013

    Report

    Report Number
    2134265-2013-04500
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: RETURNED DEVICE RECEIVED WAS CONSISTED OF AN NC QUANTUM APEX CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE. THERE WAS BLOOD IN THE WIRE LUMEN. THE HYPOTUBE WAS KINKED 71CM FROM THE STRAIN RELIEF. THE HYPOTUBE SEPARATION WAS 68CM FROM THE TIP. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. PRODUCT ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THERE WAS NO EVIDENCE THAT THE SEPARATION WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305866 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408300 15988293

    Patients

    Seq Age Sex Outcome Treatment
    1