BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3221438 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04768
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN NC QUANTUM APEX SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. 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 EDGE OF THE PROXIMAL 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50MMX12MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION. DURING FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS THEN REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.75MM X 12MM NON-BSC BALLOON CATHETER AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT¿S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50MMX12MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATATION. DURING FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS THEN REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 2.75MM X 12MM NON-BSC BALLOON CATHETER AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT¿S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319567 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412250 15770192

    Patients

    Seq Age Sex Outcome Treatment
    1