BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 1982668 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00099
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    November 16, 2010
    Report Date
    January 11, 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 CATHETER WAS RECEIVED INSIDE THE PRODUCT SHELF CARTON. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THE GUIDE WIRE LUMEN WAS STRETCHED APPROXIMATELY 7MM IN LENGTH, LOCATED APPROXIMATELY 5.2CM FROM THE DISTAL TIP OF THE CATHETER. THE INFLATION LUMEN AND GUIDE WIRE LUMEN WAS KINKED 3.2CM FROM THE DISTAL TIP. A 0.014 INCH GUIDE WIRE WAS BACKLOADED THROUGH THE TIP OF THE DEVICE AND RESISTANCE WAS ENCOUNTERED WHERE THE GUIDE WIRE LUMEN IS STRETCHED. 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

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED (B)(4)-2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, REMOVAL DIFFICULTY OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOR PRE DILATION THE PHYSICIAN ADVANCED THE 3.25MM X 12MM NC QUANTUM APEX BALLOON CATHETER. THE BALLOON WAS INFLATED FIVE TIMES TO 20ATMS EACH. A NON-BSC STENT WAS IMPLANTED. FOR POST DILATION, THE QUANTUM APEX BALLOON WAS INFLATED TO 24ATMS ON THE FIRST INFLATION AND 20ATMS ON THE SECOND INFLATION. THE BALLOON WAS FULLY DEFLATED AND UPON WITHDRAWAL, SEVERE RESISTANCE WAS ENCOUNTERED. THE DEVICE BECAME STUCK ON A NON-BSC GUIDE WIRE. THE GUIDE WIRE AND THE BALLOON CATHETER WERE REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS 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 H7493912412320 13748991

    Patients

    Seq Age Sex Outcome Treatment
    1 ENCORE26 INFLATION DEVICE