BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2221157 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03562
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 19MM FROM THE DISTAL TIP. 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 TRANSLUMINAL ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE NON TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE 3.5X20MM QUANTUM APEX NC BALLOON WAS ADVANCED TO THE MID RCA, THE BALLOON WAS SUCCESSFULLY INFLATED TO AN UNSPECIFIED PRESSURE, ON THE SECOND INFLATION TO 18 ATMS THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    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 H7493912420350 14438775

    Patients

    Seq Age Sex Outcome Treatment
    1