BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20/20 PRIORITY PACK W/COPILOT

    MDR report key: 2103022 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03685
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DTL
    PMA / PMN Number
    K991102
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COPILOT WAS RETURNED WITH BLOOD AND CONTRAST IN THE SIDEARM AND FUNNEL CAP. THERE WAS NO VISIBLE DAMAGE NOTED TO THE COPILOT. THERE ARE SEVERAL POSSIBILITIES WHICH COULD CONTRIBUTE TO LEAKS WITH A COPILOT INCLUDING, BUT NOT LIMITED TO, MANUFACTURING RELATED ANOMALIES, MATERIALS, PINCHED/DAMAGED OR OFF-SET SEALS, USE TECHNIQUE, AND ASSOCIATED DEVICES BEING USED. IN THIS CASE, THE REPORTED LEAK COULD NOT BE CONFIRMED DURING FUNCTIONAL TESTING. THE ROTATOR WAS CLOSED OFF WITH A CAP. A NEW CATHETER AND 0.014 INCH GUIDE WIRE WERE ADVANCED THROUGH THE FUNNEL CAP AND THE FUNNEL CAP WAS TIGHTENED. THERE WAS NO LEAK NOTED WHEN PRESSURIZED USING A NEW INDEFLATOR FILLED WITH WATER. AS THE COPILOT BLEEDBACK CONTROL VALVE IS TYPICALLY UNDER POSITIVE PRESSURE DURING USE, IT IS LIKELY THAT ANY LEAK WOULD CAUSE FLUID (BLOOD) TO LEAK OUT AND WOULD NOT LIKELY CAUSE AIR TO ENTER. IT MAY BE POSSIBLE THAT THE AIR BUBBLES NOTED WERE RELATED TO CONNECTIONS WITH ASSOCIATED DEVICES SUCH AS THE MANIFOLD SYSTEM OR EXTENSION TUBING; HOWEVER, THIS COULD NOT BE CONFIRMED. A CONCLUSIVE CAUSE FOR THE REPORTED AIR BUBBLES COULD NOT BE DETERMINED AS THERE WERE NO LEAKS OR AIR BUBBLES NOTED DURING FUNCTIONAL TESTING. ALL COPILOT BLEED BACK CONTROL VALVES ARE SUBJECTED TO A 100% VISUAL INSPECTION, AND A CAP COMPRESSION TEST IS PERFORMED TO VERIFY INNER DIAMETER SPECIFICATION. A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY, INCLUDING PERFORMING A LEAK TEST ON A SAMPLE OF UNITS FROM EACH LOT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: 2.5 X 8 MM TREK AND 3.25 X 8 MM NC TREK. GUIDE CATHETER: CORDIS XBLAD 5 FRENCH. STENT: 3.0 X 12 MM VISION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AIR BUBBLES WERE VISUALIZED AT THE BIFURCATION ON THE MANIFOLD OF THE COPILOT DURING WITHDRAWAL OF THE FOLLOWING DEVICES AT THE END OF THE PROCEDURE: 2.5 X 8 MM TREK, 3.0 X 12 MM VISION, 3.25 X 8 NC TREK MM. THE PHYSICIAN DREW BACK ON THE MANIFOLD TO EVACUATE THE AIR BUBBLES FROM THE SYSTEM; THEREFORE, AIR WAS NOT INJECTED INTO THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO DELAY IN THE PROCEDURE. ALL THE DEVICES WERE ABLE TO BE REMOVED. THE VISION WAS IMPLANTED IN THE MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20/20 PRIORITY PACK W/COPILOT HEMOSTATIC VALVE DTL AV-TEMECULA-CT 1031191

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention