BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3790630 · Received May 5, 2014

    Report

    Report Number
    2134265-2014-02373
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR:RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH THE ORIGINAL BOX AND A STOPCOCK ATTACHED TO THE HUB. THERE WAS BLOOD IN THE INFLATION LUMEN AND IN THE BALLOON. EXAMINATION UNDER MAGNIFICATION REVEALED A BALLOON PINHOLE 4MM FROM THE PROXIMAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE CONFIRMED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING(LAD) ARTERY. A 15MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO POST-DILATE THE LESION. HOWEVER, DURING THE FIRST INFLATION THE BALLOON RUPTURED AT AN UNSPECIFIED PRESSURE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE STATUS OF THE PATIENT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268495 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415270 16404058

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: MACH1| INTRODUCER SHEATH:TRM| STENT: PROMUS| INFLATION DEVICE: ENCORE| GUIDEWIRE: SION