BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3954685 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04371
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    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

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. EXAMINATION UNDER MAGNIFICATION REVEALED THE INNER AND OUTER SHAFT WAS BUCKLED AND STRETCHED 23MM - 30MM FROM THE DISTAL TIP (7 MM IN LENGTH). THE INNER SHAFT WAS ALSO BUCKLED NEXT TO THE PROXIMAL MARKERBAND AND THERE WAS TIP DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING WAS PERFORMED USING AN INFLATION DEVICE FILLED WITH WATER. THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE. WHEN DEFLATION WAS ATTEMPTED, THE BALLOON DEFLATED SLIGHTLY BUT NOT COMPLETELY. THE DEFLATION TIME DID NOT MEET THE PRODUCT SPECIFICATION. THE STRETCHED AND NECKED AREAS OF THE SHAFT MAY HAVE CAUSED INFLATION LUMEN RESTRICTION WHICH IS A KNOWN FACTOR FOR INHIBITING BALLOON DEFLATION. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE AROUND 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). UPON RETREATING BACK THE BALLOON, RESISTANCE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAILURE TO DEFLATE THE BALLOON OCCURRED. A 12MM X 3.00MM NC QUANTUM APEX¿ CATHETER BALLOON WAS SELECTED FOR USE TO DILATE THE LESION. DURING THE PROCEDURE, THE BALLOON COULD NOT DEFLATE. THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON SEVERAL TIMES. FIRST, BY USING AN INDEFLATOR BUT WAS UNSUCCESSFUL. THEN TRIED TO USE A 20 ML SYRINGE AND APPLIED NEGATIVE PRESSURE BUT ATTEMPT STILL FAILED. AFTERWARDS, USED THE INDEFLATOR AGAIN, TOGETHER WITH THE SYRINGE, AND APPLIED DOUBLE NEGATIVE PRESSURE. EVENTUALLY, THE BALLOON SIZE REDUCED AND THE BALLOON CAN BE TAKEN OUT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433526 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412300 16946367

    Patients

    Seq Age Sex Outcome Treatment
    1