BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3904224 · Received July 1, 2014

    Report

    Report Number
    2134265-2014-03728
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR 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

    SAME CASE AS MDR ID: 2134265-2014-03727. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANTEGRADE APPROACH. AFTER CROSSING THE LESION WITH A NON-BSC GUIDEWIRE A 2.0MMX40MMX144CM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION HOWEVER THE BALLOON RUPTURED AT 6 ATMOSPHERES. A 2.0X30MMX143CM COYOTE ES OTW WAS THEN ADVANCED BUT THE BALLOON ALSO RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A NEW 2X30MM NC MR COYOTE BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383465 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H74939282203010 16875460

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CRUISE AND OTHER| INTRODUCER SHEATH: PARENT 4.5 55CM