BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2870261 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07845
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 14, 2012
    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: A VISUAL EXAMINATION IDENTIFIED DRIED BLOOD AND CONTRAST IN THE INFLATION LUMEN AND THE BALLOON. A PINHOLE WAS NOTED ON THE BALLOON WALL 12MM FROM THE TIP. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS NO OTHER DAMAGE TO THE DEVICE. 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 THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, DIFFICULTY ADVANCING OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, SEVERELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PRE DILATED THE LESION USING A 5.0MM NON-BSC BALLOON CATHETER. A 5.0 X 12MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST DILATATION, BUT COULD NOT CROSS THE LESION. THE PHYSICIAN COMPLETED THE CASE USING A 5.0MM NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE IS A PINHOLE IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412500 15314475

    Patients

    Seq Age Sex Outcome Treatment
    1 E-CHARGE INFLATION DEVICE| 6FR HEARTRAIL GUIDE CATHETER| 0.014INCH SION GUIDE WIRE| HIRYU 5.0MM BALLOON CATHETER