BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2211419 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03302
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURED. THE 85% STENOSED DE NOVA LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 3.50X15MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR PRE-DILATION AND ADVANCED TO THE LESION WITHOUT RESISTANCE. ON THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMS AFTER BEING INFLATED FOR ABOUT 5 SECONDS. THE DEVICE WAS REMOVED INTACT .THE PHYSICIAN THEN ADVANCED A 3.50X10MM FLEXTOME OVER THE WIRE (OTW) CUTTING BALLOON. ON THE 1ST INFLATION, THE CUTTING BALLOON RUPTURED AT 4ATMS AFTER BEING INFLATED FOR ABOUT 5 SECONDS. THE PHYSICIAN ATTEMPTED TO ADVANCE A SECOND 4.00X15MM FLEXTOME OTW CUTTING BALLOON; HOWEVER, ON THE FIRST INFLATION THE CUTTING BALLOON RUPTURED AT 6ATMS AFTER BEING INFLATED FOR ABOUT 5 SECONDS. BOTH OF THE CUTTING BALLOONS WERE REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H7493912415350 14392848

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR