BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3180322 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04423
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN NC QUANTUM APEX SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. MAGNIFIED INSPECTION REVEALED THE OUTER SHAFT WAS LONGITUDINALLY TORN ADJACENT TO THE PROXIMAL BALLOON BOND. THERE WAS NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING SHOWED A TEAR IN THE OUTER SHAFT PREVENTED BALLOON INFLATION. 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 DURING PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT MAIN TRUNK. A 8MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO POST DILATE THE TARGET LESION. THE BALLOON WAS INFLATED AT 12 ATMOSPHERES ON THE FIRST INFLATION. ON THE SECOND INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE BALLOON WAS RETRIEVED INTACT AND 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 PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT MAIN TRUNK. A 8MM X 4.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO POST DILATE THE TARGET LESION. THE BALLOON WAS INFLATED AT 12 ATMOSPHERES ON THE FIRST INFLATION. ON THE SECOND INFLATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE BALLOON WAS RETRIEVED INTACT AND 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
    280356 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408450 15936296

    Patients

    Seq Age Sex Outcome Treatment
    1