BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1973124 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00522
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OF THE RETURNED DEVICE FOUND IT HAD BEEN FULLY DEPLOYED. ALL FOUR NEEDLES, BOTH SUTURES AND BOTH COILED SUTURE LUMENS WERE NOT RETURNED. THERE WAS NO DETECTED DAMAGE TO THE DEVICE. THE GUIDE WIRE DIAMETER WAS MEASURED AND NOTED TO BE ACCEPTABLE. DURING TESTING, INSERTION CAPABILITIES WERE SUCCESSFUL WITH THE GUIDE WIRE EXITING THE GUIDE WIRE EXIT PORT. NO UNUSUAL RESISTANCE WAS ENCOUNTERED EXCEPT FOR SLIGHT RESISTANCE WHEN THE GUIDE WIRE ENCOUNTERED THE HEMOSTASIS VALVE WHICH REQUIRED A SLIGHT MORE EFFORT TO CROSS. THE HEMOSTASIS VALVE WAS INSPECTED AND THERE WAS NO DETECTED ANOMALY. BASED ON THE INVESTIGATION FINDING, THE ROOT CAUSE IS COULD NOT BE DETERMINED, AS THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS DIFFICULTY ADVANCING A NON-ABBOTT GUIDE WIRE THROUGH THE PROSTAR XL DEVICE TO REMOVE THE PROSTAR XL DEVICE FROM THE PATIENT ANATOMY. THE GUIDE WIRE WOULD NOT ADVANCE PAST "THE AREA OF THE HEMOSTASIS VALVE, DISTAL OF THE GUIDE WIRE EXIT PORT OF THE PROSTAR XL DEVICE". THE GUIDE WIRE WAS RETRACTED AND INSERTED A SECOND TIME WITH MORE EFFORT AND SLIGHT PUSHING, MAKING IT POSSIBLE TO PLACE THE DEVICE AND ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 900146H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention