BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 4862852 · Received June 23, 2015

    Report

    Report Number
    2134265-2015-03733
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 26, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE DISTAL PORTION OF THE NC QUANTUM APEX BALLOON CATHETER. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES TO THE TIP OF THE DEVICE. MICROSCOPIC EXAMINATION AND TACTILE PRESENTED NO DAMAGE OR IRREGULARITIES TO THE SHAFT OF THE DEVICE. MICROSCOPIC EXAMINATION AND TACTILE INSPECTION REVEALED NUMEROUS KINKS THROUGHOUT THE HYPOTUBE AND A COMPLETE HYPOTUBE SEPARATION 85.5CM FROM THE END OF THE HYPOTUBE. THE HUB AND PROXIMAL PORTION OF THE HYPOTUBE WERE NOT RETURNED. THE HYPOTUBE FRACTURE SURFACE WAS OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 15MM X 3.00MM NC QUANTUM APEX¿ WAS SELECTED; HOWEVER, THE CATHETER SNAPPED DUE TO A RESISTANT LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 15MM X 3.00MM NC QUANTUM APEX¿ WAS SELECTED; HOWEVER, THE CATHETER SNAPPED DUE TO A RESISTANT LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404482 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415300 17799719

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR