BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2072732 · Received April 29, 2011

    Report

    Report Number
    2134265-2011-01436
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 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 MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED 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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED, DENOVO LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WAS USING A 2.0X12MM QUANTUM APEX PTCA DILATATION CATHETER FOR DILATATION AND THE BALLOON RUPTURED AT 14ATMS. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. A 2.5X32MM TAXUS LIBERTE STENT WAS IMPLANTED AND THE LESION POST DILATED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION 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 H7493912412200 13790366

    Patients

    Seq Age Sex Outcome Treatment
    1 0.014INCH SION BLUE GUIDE WIRE| 6FR RADIFOCUS 7CM SHEATH| ENCORE26 INFLATION DEVICE| 6FR HEARTRAIL JL4 GUIDE CATHETER