BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3090666 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02975
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    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 CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL FROM THE PROXIMAL TO DISTAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURED. THE 90% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS MIDDLE RIGHT CORONARY (RCA) ARTERY. AFTER CROSSING THE LESION WITH A 3.50MM X 12MM NC QUANTUM APEX BALLOON, THE DEVICE WAS INFLATED. THE FIRST AND SECOND INFLATION WERE AT 12ATM. DURING THE THIRD INFLATION THE BALLOON RUPTURED AT 12ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURED. THE 90% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS MIDDLE RIGHT CORONARY (RCA) ARTERY. AFTER CROSSING THE LESION WITH A 3.50MM X 12MM NC QUANTUM APEX BALLOON, THE DEVICE WAS INFLATED. THE FIRST AND SECOND INFLATION WERE AT 12ATM. DURING THE THIRD INFLATION THE BALLOON RUPTURED AT 12ATM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191279 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412350 15381807

    Patients

    Seq Age Sex Outcome Treatment
    1