BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2121150 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02176
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    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 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED, DE NOVO LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS UNKNOWN CORONARY VESSEL. A NON-BSC GUIDE WIRE AND GUIDE CATHETER WERE USED TO ACCESS THE LESION. A 2.5X15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION. UPON FIRST INFLATION, TO RATED BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 13931999

    Patients

    Seq Age Sex Outcome Treatment
    1 LAUNCHER GUIDE CATHETER| RUNTHROUGH GUIDE WIRE| MEDIKIT INTRODUCER SHEATH| ENCORE 26 INFLATION DEVICE