BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2972640 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00983
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 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 MANUFACTURER: THE NC QUANTUM APEX CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION. AN UNSPECIFIED 3.0MM STENT WAS ADVANCED AND DEPLOYED. NEXT A 3.0X12MM NC QUANTUM APEX BALLOON WAS ADVANCED FOR POST DILATION, HOWEVER THE BALLOON RUPTURED ON THE 1ST INFLATION AT 18 ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION. AN UNSPECIFIED 3.0MM STENT WAS ADVANCED AND DEPLOYED. NEXT A 3.0X12MM NC QUATUM APEX BALLOON WAS ADVANCED FOR POST DILATION, HOWEVER THE BALLOON RUPTURED ON THE 1ST INFLATION AT 18 ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75657 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 15382702

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR