BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TRI-LOBE BALLOON CATHETER

    MDR report key: 1020594 · Received March 28, 2008

    Report

    Report Number
    2017233-2008-00130
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. BALLOON CATHETER BROKEN. EVALUATION SUMMARY: THE RETURNED DELIVERY CATHETER WAS INSPECTED FOR VISIBLE DAMAGE. THE TRAILING FEP CUFF ON THE BALLOON CATHETER WAS DENTED IN AND SHIFTED. THE FEP CUFF WAS ATTACHED LOOSELY AND COULD BE MOVED UP AND DOWN APPROX 5 MM AND ROTATED ABOUT 180 DEGREES. THE INFLATION PORT ON THE BALLOON CATHETER MANIFOLD WAS CRACKED. A 0.035" GUIDEWIRE WAS INSERTED THROUGH THE BALLOON CATHETER, A 30 CC SYRINGE WAS ATTACHED IN THE INFLATION PORT, AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON CATHETER, HOWEVER, DUE TO THE CRACKED INFLATION PORT THE BALLOON CATHETER COULD NOT BE PRESSURIZED SUFFICIENTLY TO INFLATE THE BALLOON. TO MAINTAIN PRESSURE, THE CRACKED INFLATION PORT WAS TAPED AND PRESSURE WAS APPLIED TO THE CRACK BY HAND TO MAINTAIN SEAL. EVENTUALLY, THE BALLOON CATHETER WAS INFLATED. AN ATTEMPT WAS THEN MADE TO DEFLATE THE BALLOON. TWO OBSERVATIONS WERE MADE DURING BALLOON DEFLATION. FIRST, ALTHOUGH THE TAPE AND PRESSURE APPLIED TO THE CRACKED INFLATION PORT WAS ABLE TO MAINTAIN SUFFICIENT PRESSURE TO INFLATE THE BALLOON, IT WAS UNABLE TO MAINTAIN A VACUUM TO DEFLATE THE BALLOON. AIR WAS CONTINUALLY SUCKED INTO THE SYRINGE, WHERE IT WAS NOT ABLE TO CREATE A SUFFICIENT VACUUM TO DEFLATE THE BALLOON. SECOND, WHEN THE SYRINGE WAS REMOVED FROM THE BALLOON CATHETER, THE BALLOON CATHETER STAYED INFLATED AND DID NOT DEFLATE. WHEN THE TRAILING FEP CUFF WAS ROTATED APPROX 60 DEGREES COUNTER-CLOCKWISE, THE BALLOON CATHETER WAS DEFLATED WITHOUT ANY VACUUM. THE BALLOON DEFLATING UPON THE ROTATION OF THE TRAILING FEP CUFF SUGGESTS THAT THE LUMENS OF THE BALLOON CATHETER WERE TWISTED AND KINKED, AND THE ROTATION OF THE TRAILING FEP CUFF WAS SUFFICIENT TO UN-KINK THE LUMEN. THE TRAILING FEP CUFF BECOMING UN-BONDED CAUSING TWISTING AND KINKING OF THE LUMEN DURING USE AND A CRACK ON THE INFLATION PORT PREVENTING A VACUUM FROM FORMING IN THE INFLATION LUMEN ARE THE ROOT CAUSES FOR THE EVENT. THIS TYPE OF OCCURRENCE WILL CONTINUE TO BE TRENDED AND APPROPRIATE ACTIONS TAKEN AS THEY ARE DEEMED NECESSARY.

    Description of Event or Problem · 1

    IN 2008, TWO GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED TO REPAIR A DESCENDING THORACIC AORTIC ANEURYSM. DURING THE PROCEDURE, THE BALLOON ON A GORE TRI-LOBE BALLOON CATHETER WAS INFLATED AND DEFLATED MULTIPLE TIMES. IN ADDITION, THE GORE TRI-LOBE BALLOON CATHETER WAS INSERTED, REMOVED, AND REINSERTED THROUGH A GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE. WHEN THE GORE TRI-LOBE BALLOON CATHETER WAS USED FOR THE LAST TIME, THE PHYSICIAN HAD DIFFICULTY DEFLATING THE BALLOON. THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON AND REMOVE THE GORE TRI-LOBE BALLOON CATHETER. THE NEXT MONTH, THE PT WAS ADMITTED TO THE EMERGENCY ROOM FOR BACK PAIN AND CHEST PRESSURE. A COMPUTED TOMOGRAPHY SCAN REVEALED A SMALL TEAR IN THE DESCENDING THORACIC AORTA. THE NEXT DAY, AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED AND THE TEAR WAS SUCCESSFULLY REPAIRED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TRI-LOBE BALLOON CATHETER BALLOON CATHETER DQY W.L. GORE & ASSOCIATES, INC WLG360 05652864

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention