BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3241239 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-04984
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE AN NC QUANTUM APEX PRODUCT POUCH THAT MATCHED THE INFORMATION ON THE DEVICE. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 1MM FROM THE DISTAL END OF THE DISTAL MARKERBAND. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED UNSPECIFIED CORONARY VESSEL. THE 8MM X 2.75MM NC QUANTUM APEX¿ BALLOON CATHETER WAS USED TO PREDILATE THE LESION AND ON THE SECOND INFLATION IT RUPTURED AT UNKNOWN ATMS. THE DEVICE WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED UNSPECIFIED CORONARY VESSEL. THE 8MM X 2.75MM NC QUANTUM APEX BALLOON CATHETER WAS USED TO PREDILATE THE LESION AND ON THE SECOND INFLATION IT RUPTURED AT UNKNOWN ATMS. THE DEVICE WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340285 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408270 15269857

    Patients

    Seq Age Sex Outcome Treatment
    1