BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2222251 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03200
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 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) BALLOON CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING. THERE WAS BLOOD AND CONTRAST IN THE HUB AND WIRE LUMEN. INSPECTION OF THE BALLOON REVEALED A PINHOLE IN THE BALLOON WALL ON THE PROXIMAL END OF THE BALLOON. THE SHAFT BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS HAD MULTIPLE KINKS. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL PRESENTED NO INDICATION OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE PINHOLE. 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 PERCUTANEOUS CORONARY ARTERY INTERVENTIONAL TREATMENT PROCEDURE A BALLOON BURST OCCURRED. THE 90% STENOSED TARGET LESION WAS IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PHYSICIAN TREATED THE LESION USING AN NC QUANTUM APEX MR 8MM X 3.50MM BALLOON CATHETER. UPON 4TH INFLATION, THE BALLOON RUPTURED AT UNKNOWN ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED COMPLICATION 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 H7493912408350 14053425

    Patients

    Seq Age Sex Outcome Treatment
    1