BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2010591 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00550
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 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: (B)(6). DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED A BALLOON PINHOLE. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE, WHICH CONFIRMED A PINHOLE ON THE DISTAL END OF THE BALLOON WALL PARALLEL WITH THE DISTAL EDGE OF THE MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS BLOOD AND CONTRAST PRESENT THROUGHOUT THE DISTAL LUMEN AND BALLOON. 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 INTERVENTIONAL PROCEDURE A BALLOON RUPTURE OCCURRED. ACCESS WAS GAINED THROUGH THE RADIAL ARTERY. THE 99% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 2.0X8MM NC QUANTUM APEX MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WHERE THE BALLOON RUPTURED AT 8 ATMS ON THE INITIAL INFLATION. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT 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 H7493912408200 13751095

    Patients

    Seq Age Sex Outcome Treatment
    1