BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2024188 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01835
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE LOOSELY FOLDED BALLOON, SHAFT, CO-PILOT, GUIDE WIRE, NON-ABBOTT GUIDING CATHETER AND NON-ABBOTT INTRODUCER SHEATH. THERE WAS CONTRAST IN THE BALLOON. THIS IS CONSISTENT WITH PREPARATION AND USE OF THE PRODUCTS IN THE PATIENT ANATOMY. THE BALLOON CATHETER WAS RETURNED ADVANCED THROUGH A COPILOT, A NON-ABBOTT GUIDING CATHETER AND THROUGH A NON-ABBOTT INTRODUCER SHEATH. THE DISTAL TAPER AND SHOULDER WERE BUNCHED. THERE WAS A BEND IN THE HYPOTUBE AT THE DISTAL END OF THE STRAIN RELIEF TUBING. AN UNKNOWN ABBOTT GUIDE WIRE WAS RETURNED BACK LOADED THROUGH THE BALLOON CATHETER. THERE WAS 20 CM OF THE DISTAL END OF THE GUIDE WIRE EXTENDING FROM THE BALLOON CATHETER TIP. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. THERE WERE TWO BENDS IN THE NON-ABBOTT GUIDING CATHETER DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO DAMAGE NOTED TO THE INTRODUCER SHEATH. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A DILATATION CATHETER AFTER INFLATION MAY INCLUDE: INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, DAMAGE TO THE GUIDING CATHETER OR INTRODUCER SHEATH. THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE INTRODUCER SHEATH DUE TO THE BUNCHED DISTAL TAPER AND SHOULDER. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO INFLATE AND DEFLATE THE BALLOON. AFTER THE BALLOON WAS DEFLATED, THE INTRODUCER SHEATH WAS REMOVED WITH STRONG RESISTANCE AT THE BUNCHED DISTAL TAPER AND SHOULDER. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON CATHETER FROM THE NON-ABBOTT GUIDING CATHETER BUT THE CATHETER WAS NOT ABLE TO BE REMOVED. AFTER THE BALLOON CATHETER AND GUIDING CATHETER WERE SOAKED IN THE WATER BATH FOR THREE DAYS, THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE GUIDING CATHETER. THE GUIDE WIRE COULD NOT BE REMOVED FROM THE BALLOON CATHETER. AS THIS IS A HIGH PRESSURE BALLOON WITH A LARGE DIAMETER, THE BALLOON PROFILE IS OFTEN NOT AS SMALL ONCE THE BALLOON HAS BEEN INFLATED. IT WAS REPORTED THAT THE VOYAGER NC WAS USED FOR POST DILATATION WHICH MAY HAVE DISRUPTED THE BALLOON TRI FOLD AND PROFILE SUCH THAT RESISTANCE WAS NOTED DURING INTERACTION WITH THE GUIDE CATHETER. ADDITIONALLY, AS RESISTANCE WAS ENCOUNTERED DURING RETRACTION, IT WOULD HAVE CONTRIBUTED TO THE BALLOON BUNCHING AS NOTED ON THE RETURNED PRODUCT. IT SHOULD BE NOTED THAT THE VOYAGER NC INSTRUCTIONS FOR USE WARNS: WITH 4.5 MM AND 5.0 MM BALLOON DILATATION CATHETERS, SOME INCREASED RESISTANCE MAY BE NOTED UPON INSERTION OR WITHDRAWAL INTO OR OUT OF THE GUIDING CATHETER. CHOOSING A LARGER GUIDING CATHETER SIZE MAY MINIMIZE THIS. IT DOES NOT APPEAR THAT THE NOTED BENDS AND KINKS IN THE CATHETER CONTRIBUTED TO THE REPORTED DIFFICULTIES; THEREFORE IT IS LIKELY THEY OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL DILATATION CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL DILATATION OF A LESION LOCATED IN THE RIGHT CORONARY ARTERY, WHICH WAS NOT TORTUOUS OR CALCIFIED, RESISTANCE WAS FELT WHILE TRYING TO RETRACT THE BALLOON INTO A NON-ABBOTT GUIDING CATHETER. ALL OF THE DEVICES WERE WITHDRAWN AS ONE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0100761

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR