BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2220545 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03474
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE DEVICE WAS RECEIVED WITH NO OTHER DEVICES OR ORIGINAL PACKAGING. THERE WAS BLOOD AND CONTRAST IN THE HUB, INFLATION LUMEN AND BALLOON. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE FILLED WITH WATER, WHICH REVEALED A PINHOLE. THE PINHOLE WAS LOCATED IN THE BALLOON WALL MATERIAL ON THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. 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 LESION BEING TREATED WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE 5.0X8MM NC QUANTUM APEX BALLOON WAS ADVANCED TO POST DILATE AN UNKNOWN STENT IN THE MID RCA. THE BALLOON WAS INFLATED TO 8 ATMS AND THE BALLOON RUPTURED ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND 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 H7493912408500 13744323

    Patients

    Seq Age Sex Outcome Treatment
    1