BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILER BALLOON CATHETER

    MDR report key: 1203671 · Received October 9, 2008

    Report

    Report Number
    1319211-2008-00041
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    August 27, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE REPORTED LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVAL AND THE FOLLOWING WAS OBSERVED: THE BALLOON CATHETER WAS RETURNED WITH THE SHEATH. THE BALLOON IS ALL BUNCHED UP ON THE TIP OF THE SHAFT. AFTER SOAKING THE BALLOON IN WARM WATER, WE WERE ABLE TO STRAIGHTEN THE BALLOON OUT TO LOOK FOR THE BURST. THERE ARE THREE LITTLE LONGITUDINAL BURSTS, OBSERVED ON THE BALLOON. A CIRCUMFERENTIAL BURST WAS NOT OBSERVED. THE NECK OF THE BALLOON IS NOT BONDED. IT APPEARS AS IF THE BOND MAY HAVE BROKE WHEN THE CATHETER WAS PULLED OUT. CONCLUSION: THE COMPLAINT INVESTIGATION CONFIRMED THE BALLOON BURST. DURING THE EVAL OF THE RETURNED SAMPLE, 3 LONGITUDINAL BURSTS WERE OBSERVED IN THE BALLOON. THE REPORTED CIRCUMFERENTIAL BURST WAS NOT OBSERVED. THE NECK OF THE BALLOON IS NO LONGER BONDED AND THE BALLOON WAS BUNCHED UP AT THE TIP OF THE CATHETER. THE BALLOON BURST APPEARS TO HAVE BEEN CAUSED DUE TO OVER INFLATION OF THE BALLOON. PRIOR TO RELEASE, THE BALLOONS ARE 100% INSPECTED. DURING THIS PROCESS EVERY BALLOON IS INFLATED, THE OD OF THE BALLOON IS MEASURED, AND THE BALLOON IS SUBMERGED IN A TUB OF WATER TO VERIFY THAT THE BALLOON DOES NOT LEAK. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL OF THE DEVICE SPEC AND QUALITY REQUIREMENTS WERE SATISFIED. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    ON THE 3RD INFLATION OF THE BALLOON USING MORE THAN THE RATED BURST PRESSURE, WHICH IS 14ATM (ABOUT 18-20ATM) THE BALLOON WAS BURST. THE DOCTOR WAS NOT ABLE TO TAKE THE BALLOON OUTSIDE THE CEPHALIC VEIN, AS HE COULD NOT CROSS THE SHEATH. A SURGEON WAS CALLED FOR OPENING THE VEIN, AND PULL OUT THE BALLOON FROM THE VEIN. IT SEEMS THAT THE BALLOON WAS BURST ALONG THE DIAMETER AND NOT ALONG THE LENGTH OF THE BALLOON. THE COMPLAINT IS ABOUT THE WAY THE BALLOON WAS BURST AND NOT WHY, AS DR USED MORE THAN 14ATM PRESSURE (USING 18-20ATM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILER BALLOON CATHETER TRANSLUMINAL ANGIOPLASTY BALLOON CATHET DQO ANGIODYNAMICS, INC. 924355

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention