BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 976743 · Received January 8, 2008

    Report

    Report Number
    1319211-2007-00042
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    December 4, 2007
    Report Date
    December 28, 2007
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE RETURNED LOT NUMBERS (936656, 934452, 924443, 928405) 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 SAMPLES WERE RETURNED FOR EVALUATION AND THE FOLLOWING WAS OBSERVED: RETURNED FOR EVALUATION WERE 3 STERILE SAMPLES (2 FROM 936656 AND 1 FROM 934452) AND 4 OPENED SAMPLES (1 FROM 936656, 1 FROM 924443 AND 2 FROM 928405). THE EVALUATION OF THE RETURNED OPENED SAMPLES SHOWED THE FOLLOWING: LOT 936656- THE BALLOON IS MISSING AND THE FIRST 6CM OF THE CATHETER ARE SEVERELY STRETCHED. LOT 924443- THE BALLOON CATHETER WAS RETURNED AND HAS NOT BEEN INFLATED. THERE IS A 1CM STRETCHED SECTION 15CM FROM THE TIP. LOT 928405- THE PACKAGING, WHICH HAS "WOULD NOT DEFLATE" WRITTEN ON IT, HAS BEEN INFLATED, BUT WAS PUNCTURED TO DEFLATE. THERE IS A .5CM STRETCHED SECTION 12CM FROM THE DISTAL TIP. THE OTHER PACKAGING HAS A #2 WRITTEN ON IT, BUT THE CATHETER WAS NOT RETURNED. THE EVALUATION OF THE RETURNED STERILE SAMPLES SHOWED THE FOLLOWING: ONE STERILE SAMPLE WAS REMOVED FROM ITS ORIGINAL PACKAGING; THE PROTECTIVE SLEEVE AND PACKAGING MANDREL WERE REMOVED WITHOUT DIFFICULTY. NO STRETCHED SECTIONS WERE OBSERVED ON THE SHAFT. THE BALLOON WAS THEN INFLATED AND DEFLATED WITHOUT DIFFICULTY. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. DURING THE EVALUATION OF THE OPENED RETURNED SAMPLES, STRETCHED SECTIONS WERE OBSERVED ON THE CATHETER SHAFTS AND ONE SAMPLE HAD BEEN PUNCTURED IN ORDER TO DEFLATE THE BALLOON. DURING THE EVALUATION OF THE STERILE BALLOON CATHETER, THE PACKAGING MANDREL AND PROTECTIVE SLEEVE WERE REMOVED WITHOUT DIFFICULTY, THE BALLOON WAS INFLATED AND DEFLATED WITHOUT DIFFICULTY AND NO STRETCHED SECTIONS WERE OBSERVED. IT IS BELIEVED THE STRETCHED SECTIONS ON THE CATHETER SHAFTS INTERFERED WITH THE INFLATION AND DEFLATION OF THE BALLOONS. POSSIBLE CAUSES OF STRETCHED SECTIONS ARE THE METHOD OF REMOVAL OF THE PROTECTIVE SLEEVE AND PACKAGING MANDREL OR FLARE ON THE PROTECTIVE SLEEVE, WHICH CAN STRETCH THE CATHETER SHAFT WHEN EXCESSIVE FORCE IS USED TO GRIP THE PROTECTIVE SLEEVE AS IT IS REMOVED. 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. IF THE STRETCHED SECTION OCCURRED DURING THE MANUFACTURING PROCESS, IT WOULD HAVE BEEN DETECTED DURING THIS INSPECTION. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING TO HELP PREVENT STRETCHING FROM HAPPENING: "PROPER FUNCTIONING OF THE CATHETER DEPENDS ON ITS INTEGRITY. CARE SHOULD BE USED WHEN HANDLING THE CATHETER. DAMAGE MAY RESULT FROM KINKING, STRETCHING, OR FORCEFUL WIPING OF THE CATHETER." THESE TYPES OF COMPLAINTS WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    THE 6X6 BALLOONS WOULD NOT DEFLATE OR SOMETIMES INFLATE; HAD TO USE WIRE AND NEEDLE TO DEFLATE BALLOON IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II BALLOON CATHETER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY LIT ANGIODYNAMICS SEVERAL

    Patients

    Seq Age Sex Outcome Treatment
    1