BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2170616 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02892
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 27, 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

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE DEVICE WAS REMOVED INTACT. 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 13816006

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER:TERUMO| INTRODUCER:TERUMO| GUIDE CATHETER: MACH1