BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2211484 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03274
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 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 NC QUANTUM APEX MONORAIL (MR) DEVICE WAS RECEIVED FOR ANALYSIS IN THE PRODUCT HOOP. THERE WAS BLOOD AND CONTRAST IN THE HUB AND WIRE LUMEN. THE BALLOON WAS INSPECTED UNDER MAGNIFICATION AND A PINHOLE WAS CONFIRMED IN THE BALLOON WALL LOCATED ON THE PROXIMAL END OF THE BALLOON. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RADIO OPAQUE MARKERS. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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. ACCESS WAS GAINED VIA THE FEMORAL ARTERY USING A NON-BSC 7F SHEATH, 7F GUIDE CATHETER AND A .014" GUIDE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN ENCORE 26 INFLATION DEVICE WAS USED. AN 8X3.50MM QUANTUM APEX MONORAIL BALLOON CATHETER RUPTURED AT 12ATM WHILE BEING USED IN AN ATTEMPT TO PRE-DILATE THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 H7493912408350 14055839

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GUIDE WIRE: 0.014" SION| INTRODUCER SHEATH: 7F MEDIKIT| INFLATION DEVICE: ENCORE26| GUIDE CATHETER: 7F LAUNCHER EBU 3.5