BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2063437 · Received April 19, 2011

    Report

    Report Number
    2134265-2011-01166
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 INTERVENTIONAL PROCEDURE A BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. ACCESS WAS GAINED THROUGH THE RADIAL ARTERY. THE 75% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA). DIRECT STENTING WAS PERFORMED TO THE RCA WITH A 3.5X18MM NON-BSC STENT. ANGIOGRAPHY WAS PERFORMED AND CONFIRMED THAT THE STENT WAS NOT FULLY EXPANDED. THE 3.5X8MM NC QUANTUM APEX BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WHERE THE BALLOON RUPTURED AT 18 ATM ON THE SECOND INFLATION. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT NON- BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT 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 13790856

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: VISION 3.5X18| INFLATION DEVICE: EVEREST| GUIDE CATHETER: TERUMO 6F JR4| GUIDE WIRE: TERUMO RUNTHROUGH