BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2850357 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07359
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 5, 2012
    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). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN, WIRE LUMEN AND THE BALLOON. THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT OF HAVING POSITIVE PRESSURE APPLIED. A PINHOLE WAS NOTED ON THE BALLOON. TO VERIFY THE PINHOLE, POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL 4MM DISTAL FROM THE PROXIMAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS NO OTHER DAMAGE TO THE DEVICE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS UNSPECIFIED VESSEL. THE 2.5X15MM NC QUANTUM APEX MR BALLOON CATHETER WAS ADVANCED, HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS CURRENT CONDITION IS GOOD. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 14737121

    Patients

    Seq Age Sex Outcome Treatment
    1