BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 2173531 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05098
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVALUATION SUMMARY: EVALUATION OF THE COPILOT FOUND IT WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE, THE CAP WAS NOT COMPLETELY CLOSED AND THE O-RING WAS IN PLACE. THE BLACK CLAMP SEAL AND BLEED BACK CONTROL (BBC) SEAL WERE ALSO INTACT. THERE WAS NO DAMAGE NOTED TO THE COPILOT. THERE ARE SEVERAL POSSIBILITIES WHICH COULD CONTRIBUTE TO LEAKS WITH A COPILOT, INCLUDING, BUT ARE NOT LIMITED TO: MANUFACTURING RELATED ANOMALIES, MATERIALS, PINCHED/DAMAGED OR OFF-SET SEALS, USE TECHNIQUE, AND ASSOCIATED DEVICES BEING USED. DURING FUNCTIONAL TESTING, THE REPORTED COMPLAINT WAS CONFIRMED. USING A CAP, THE MALE PORTION WAS CAPPED OFF AND A NEW INDEFLATOR WAS ATTACHED TO THE FEMALE PORT. THE INDEFLATOR WAS FILLED WITH WATER AND A GUIDE WIRE AND BALLOON CATHETER WERE INSERTED INTO THE COPILOT. THE COPILOT WAS PRESSURIZED TO 30 ATMOSPHERES AND FLUID WAS OBSERVED LEAKING FROM THE CAP. THE CAP WAS REMOVED FROM THE COPILOT AND A SMALL TEAR WAS OBSERVED IN THE BBC SEAL. ALTHOUGH A DEFINITIVE CAUSE FOR THE TEAR COULD NOT BE DETERMINED, IT MAY BE POSSIBLE THAT DURING INSERTION OF DEVICE, THE CAP WAS NOT FULLY DEPRESSED CAUSING THE BBC SEAL TO ONLY BE PARTIALLY OPENED. IF THE BBC IS ONLY PARTIALLY OPENED, THE SEAL MAY BECOME DAMAGED DURING INSERTION OF INTERVENTIONAL DEVICES. TO ENSURE THIS IS NOT MANUFACTURING RELATED, ALL COPILOT BLEED BACK CONTROL VALVES ARE SUBJECT 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS, INCLUDING THE COPILOT SUB-ASSEMBLY, DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED LEAK APPEARS TO BE RELATED TO THE TEAR IN THE BBC SEAL, AND A CONCLUSIVE CAUSE FOR THE TEAR COULD NOT BE DETERMINED. THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE FIRST DEVICE WAS INSERTED INTO THE COPILOT, BLOOD WAS OBSERVED LEAKING FROM THE COPILOT. THEREFORE, THE DEVICE WAS REPLACED WITH A NEW DEVICE TO CONTINUE WITH THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT MAV AV-TEMECULA-CT 1030791

    Patients

    Seq Age Sex Outcome Treatment
    1