BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPILOT BLEEDBACK CONTROL VALVE

    MDR report key: 1911627 · Received December 1, 2010

    Report

    Report Number
    2024168-2010-02572
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    AV-MURRIETA
    Product Code
    DTL
    PMA / PMN Number
    K991102
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. DILATATION CATHETER: MAVERICK; GUIDE WIRE: RUNTHROUGH NS, TERUNO; STENT: XIENCE V. EVALUATION SUMMARY: THE COPILOT WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST. THE CAP WAS RETURNED IN THE OPENED POSITION. THERE WAS NO 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. THE REPORTED LEAK COULD NOT BE CONFIRMED DURING FUNCTIONAL TESTING. A NEW GUIDE WIRE WAS INSERTED THROUGH THE COPILOT, AFTER CLOSING THE CAP, THE COPILOT WAS PRESSURIZED USING A NEW INDEFLATOR AND STOPCOCK. THERE WAS NO LEAK NOTED. IT MAY BE POSSIBLE THAT THE CLAMP SEAL WAS NOT FULLY CLOSED ALLOWING AIR TO ENTER. THE BLEEDBACK CONTROL VALVE DEVICE CONTAINS TWO SEALS. ONE SEAL (BBCV) IS OPENED AND CLOSED BY DEPRESSING OR RELEASING THE CAP. THE OTHER SEAL (CLAMP) IS OPENED AND CLOSED BY ROTATING THE CAP IN EITHER A COUNTER-CLOCKWISE OR CLOCKWISE DIRECTION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED LEAK COULD NOT BE DETERMINED AS THERE WERE NO LEAKS NOTED DURING FUNCTIONAL TESTING AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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. ADDITIONALLY, 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. IN THIS CASE IT WAS REPORTED THAT A SMALL AMOUNT OF AIR ENTERED THE PATIENT'S VESSEL. IT SHOULD BE NOTED THAT THE WARNING SECTION OF THE COPILOT INSTRUCTION FOR USE WARNS "DO NOT INJECT ANY FLUID IF AIR BUBBLES ARE VISIBLE WITHIN THE COPILOT BLEEDBACK CONTROL VALVE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COPILOT CAP COULD NOT BE LOCKED TIGHTLY, RESULTING IN AIR ENTERING THE SYSTEM, AND A SMALL AMOUNT OF AIR INTO THE PATIENT'S VESSEL DURING THE PERCUTANEOUS CORONARY INTERVENTION. THERE WERE NO ADVERSE EFFECTS DUE TO THE LEAKING OF AIR INTO THE VESSEL. THE PHYSICIAN STOPPED THE PROCEDURE AND FOUND A LOT OF AIR IN THE LUMEN OF THE COPILOT. THE COPILOT WAS REPLACED WITH A NEW ONE AND THE PROCEDURE CONTINUED. NO PATIENT EFFECTS WERE REPORTED. PATIENT HEALTH STATUS IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPILOT BLEEDBACK CONTROL VALVE HEMOSTATIC VALVE DTL AV-MURRIETA 0081192

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other