BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2023503 · Received March 18, 2011

    Report

    Report Number
    2134265-2011-00781
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER:THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    SAME CASE AS MFR# 2134265-2011-00789. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD A TAXUS EXPRESS2 STENT IMPLANTED FIVE YEARS PRIOR IN THE RCA WHICH NOW APPEARED TO BE UNDER DEPLOYED AND POSSIBLY RESTENOSED. ROTATIONAL ATHERECTOMY WAS PERFORMED IN THE LESION AND THEN A 4.0X15MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION FOR POSTDILATION. UPON THE FIRST INFLATION TO 24 ATMS FOR 20 SECONDS THE BALLOON RUPTURED. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT AND ANGIOGRAPHY CONFIRMED NO DISSECTIONS. THE PATIENT WAS WATCHED FOR FIVE MINUTES AND FINAL ANGIOGRAMS CONFIRMED NO CHANGES. THE PROCEDURE WAS ENDED AT THIS POINT WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS STABLE.

    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 H7493912415400

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ROTAWIRE FLOPPY GUIDE WIRE| 8FR FR4 MACH 1 GUIDE CATHETER| ROTABLATOR 1.75, 2.0 BURR| TAXUS EXPRESS2 STENT