BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3812459 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02602
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR; THE BALLOON WAS TIGHTLY FOLDED. THERE WERE MULTIPLE HYPOTUBE KINKS. THE HYPOTUBE WAS FRACTURED 37.5CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. 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 CONFIRMED DAMAGE. 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 LEFT CIRCUMFLEX ARTERY. A 12MM X 3.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS USED TO POST DILATE THE LESION, HOWEVER DURING THE PROCEDURE THE CATHETER SHAFT "SNAPPED" BUT IT DID NOT EXIT THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 12MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER WAS USED TO POST DILATE THE LESION, HOWEVER DURING THE PROCEDURE THE CATHETER SHAFT "SNAPPED" BUT IT DID NOT EXIT THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291815 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 16822709

    Patients

    Seq Age Sex Outcome Treatment
    1