BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1953026 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00098
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED CATHETER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON, WHICH WAS PARTIALLY INFLATED WITH CONTRAST. THIS IS CONSISTENT WITH PREPARATION OF THE DEVICE FOR USE AND AN ATTEMPT TO INFLATE THE BALLOON. THERE WAS ALSO BLOOD FOUND IN THE INFLATION LUMEN AND BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK. THE INFLATION DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE AIDED THE INVESTIGATION. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON CATHETER AND THE ANALYSIS REVEALED FLUID LEAKING FROM THE NOSEPIECE, CONFIRMING THE REPORTED LEAK. THE SINGLE ARM (HUB) AND ATTACHED NOSEPIECE WERE NOT LOOSE AND THERE WERE NO CRACKS VISIBLE. FURTHER ANALYSIS NOTED SLIGHT DELAMINATION IN THE FUSED AREA OF THE STRAIN RELIEF TUBING. FACTORS THAT CAN CONTRIBUTE TO LEAKS AT THE NOSEPIECE MAY INCLUDE, BUT ARE NOT LIMITED TO, OVER TORQUING THE SINGLE ARM AND NOSEPIECE DURING MANUFACTURING OR WITH THE INFLATION DEVICE DURING USE, MISALIGNMENT OF THE NOSEPIECE AS IT IS TORQUED, MATERIAL DEFICIENCIES, DAMAGE TO THE HYPOTUBE, HANDLING AT THE ACCOUNT. ALTHOUGH THE EXACT CAUSE FOR THE LEAK CANNOT BE DETERMINED, IT IS POSSIBLE THAT THE HUB, NOSEPIECE AND/OR ADAPTION CUP WERE DAMAGED DURING MANUFACTURING SUCH THAT WHEN POSITIVE PRESSURE WAS APPLIED TO THE SYSTEM DURING THE PROCEDURE, THE BALLOON WAS STILL ABLE TO PARTIALLY INFLATE, BUT LEAKED FROM THE NOSEPIECE. THEN, WHEN NEGATIVE PRESSURE WAS APPLIED IN ATTEMPT TO DEFLATE THE BALLOON, BLOOD PRESENT ON THE GLOVES FROM THE PROCEDURE DURING HANDLING TO DEFLATE THE BALLOON MAY HAVE INTRODUCED BLOOD INTO THE INDEFLATOR AND CATHETER AS NO OTHER LEAKS WERE NOTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED LEAKS FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. ALL BALLOON DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOYAGER NC WAS INSERTED FOR POST DILATATION OF THE 3.5 X 28 XIENCE V STENT IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL AND DIAGONAL ARTERY. THE VOYAGER NC BALLOON APPEARED TO INFLATE, BUT THE NON-ABBOTT INFLATION DEVICE WAS NOT HOLDING PRESSURE. THE VOYAGER NC WAS DEFLATED AND REMOVED FROM THE PATIENT WITHOUT ISSUE. BOTH THE INFLATION DEVICE AND THE VOYAGER NC WERE REPLACED WITH ANOTHER NON-ABBOTT INFLATION DEVICE AND A SECOND VOYAGER NC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0100461

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR STENT: 3.5 X 28 MM XIENCE V