BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2771689 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06237
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE NC QUANTUM APEX CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE OR IRREGULARITIES. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM GUIDEWIRE LUMEN. THERE WAS A HOLE IN THE INNER SHAFT 11 CM PROXIMALLY FROM THE GUIDEWIRE EXIT NOTCH. THE DIAMETER OF THE HOLE WAS SLIGHTLY LARGER THAN THE OUTER DIAMETER (OD) OF A .014" GUIDE WIRE AND MAY BE CONSISTENT WITH PERFORATION OF THE SHAFT WALL WITH THE END OF A GUIDEWIRE DURING CLINICAL USE OR PREPARATION FOR CLINICAL USE. THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED BALLOON BURST AND INFLATION DIFFICULTY; THOUGH THERE WAS NO DAMAGE TO THE BALLOON. FUNCTIONAL TESTING CONFIRMED THAT THE HOLE IN THE INNER 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 A STENTING TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. FOLLOWING THE PLACEMENT OF AN UNKNOWN STENT IN AN UNKNOWN VESSEL, THE 20MM X 2.75MM QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE STENT TO BE USED FOR POST-DILATATION, BUT WOULD NOT FULLY INFLATE. BLOOD RETURNED INTO THE BALLOON AND IT RUPTURED AT UNKNOWN ATMS. THE RUPTURED BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, BALLOON RUPTURE OCCURRED. FOLLOWING THE PLACEMENT OF AN UNKNOWN STENT IN AN UNKNOWN VESSEL, THE 20MM X 2.75MM QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE STENT TO BE USED FOR POST-DILATATION BUT WOULD NOT FULLY INFLATE. BLOOD RETURNED INTO THE BALLOON AND IT RUPTURED AT UNKNOWN ATMS. THE RUPTURED BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H7493912420270 14951909

    Patients

    Seq Age Sex Outcome Treatment
    1