BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 2091531 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03521
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 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. SHEATH: 8FR. GUIDE WIRE: RADI FORCUS. GUIDE CATH: LAUNCHER 8F JR 4. STENT: SMART. EVALUATION SUMMARY: THE COPILOT WAS RETURNED WITH BLOOD IN THE CAP, CONSISTENT WITH THE REPORTED USE. THERE WAS FLUID IN THE BODY OF THE COPILOT. THE SEALS AND O RING WERE INTACT. THE CAP WAS IN A CLOSED POSITION. THE GUIDE WIRE AND CATHETER USED IN THE PROCEDURE WERE NOT RETURNED. THE REPORTED LEAK WAS CONFIRMED. USING A NEW INDEFLATOR WITH WATER AND A STOPCOCK, THE COPILOT WAS ATTACHED TO THE INDEFLATOR AND PRESSURIZED TO 30 ATMOSPHERES WITH THE CAP TIGHTLY CLOSED. THE CAP WAS OPENED SLIGHTLY AND FLUID FLOWED OUT OF THE CAP BEFORE PUSHING DOWN ON THE CAP. THE CAP WAS REMOVED AND THERE WAS A HOLE NOTED IN THE MIDDLE OF THE BLEEDBACK CONTROL (BBC) VALUE SEAL. THE SEAL DID NOT CLOSE UP COMPLETELY. ALTHOUGH A DEFINITIVE CAUSE FOR THE HOLE COULD NOT BE DETERMINED, IT MAY BE POSSIBLE THAT DURING INSERTION OF DEVICES, 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. OTHER 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR LEAKS REPORTED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR LEAKS REPORTED FOR THIS LOT. ALL COPILOT BLEEDBACK CONTROL VALVES ARE SUBJECT TO A 100% VISUAL INSPECTION, AND A CAP COMPRESSION TEST IS PERFORMED TO VERIFY INNER DIAMETER SPECIFICATION. ADDITIONALLY, A LEAK TEST IS PERFORMED ON A SAMPLE OF UNITS FROM EACH LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COPILOT DEVICE WAS BEING USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHY PROCEDURE OF AN UNSPECIFIED ABDOMINAL ARTERY. AFTER A NON-ABBOTT GUIDE WIRE CROSSED THROUGH TO THE TREATMENT SITE, SEVERAL ATTEMPTS WERE MADE TO INSERT A NON-ABBOTT STENT THROUGH THE COPILOT BLEED BACK CONTROL VALVE; HOWEVER, BLOOD WAS NOTED TO BE LEAKING (BADLY) THROUGH THE VALVE. THE COPILOT WAS CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE AND A NON-ABBOTT STENT WAS ABLE TO CROSS THROUGH THE COPILOT, WITHOUT LEAKING, FOR TREATMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO REPORTED RISK OF SIGNIFICANT BLOOD LOSS. NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE WAS 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 1020192

    Patients

    Seq Age Sex Outcome Treatment
    1