BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1904598 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02944
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-REDWOOD CITY
    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). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.(B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE SHEATH APPEARED NORMAL. NO KINK WAS FOUND ON THE SHEATH. DURING THE INVESTIGATION, THE GUIDEWIRE WAS BACKLOADED AND FRONTLOADED WITHOUT A PROBLEM. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION; THEREFORE, THE ROOT CAUSE FOR REPORTED EVENT COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE 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

    WE ARE REPORTING 3 OF THE SAME DEVICE.FIRST DISPOSABLE FAILED AND AFTER REMOVING FROM PATIENT NOTED THE BALLOON APPEARED TO BE FUSED IN ONE AREA. 2ND AND 3RD DISPOSABLE WERE USED AND EACH TIME THE THERMACHOICE MACHINE FAILED AFTER THIRD ONE FAILED IMMEDIATELY. CALLED THE COMPANY REP AND SHE CAME IN TO EVAL THE SITUATION. NO RESOLVE OF PROBLEM AFTER SHE SPOKE TO MFG TECHNICAL SUPPORT. SEVERAL OF OUR DISPOSABLE CORDS WERE USED DURING TROUBLE SHOOTING. IN THE CLEANUP PROCESS, THE DEVICES WERE NOT KEPT ISOLATED IN THE CORRECT PACKAGES SO ID BY STAFF WAS NOT POSSIBLE. THE MFG REP DID GIVE THE FIRST DEVICE # TO HER COMPANY BUT WE HAVE NO ACCESS TO THAT INFORMATION AT PRESENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================STAFF DOESN'T KNOW EXCEPT FOR FIRST DEVICE WHERE THE BALLOON WAS "FUSED."

    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 GUIDE WIRE PORT PRIOR TO REMOVAL OF THE PROSTAR XL DEVICE FROM THE PATIENT'S 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 RE-INSERTED. WITH "MORE EFFORT AND SLIGHT PUSHING", THE GUIDE WIRE WAS SUCCESSFULLY ADVANCED. THE PHYSICIAN COMMENTED "THIS IS NOT REALLY PROPER HANDLING" TO HIM. HEMOSTASIS WAS ACHIEVED WITH THE PROSTAR XL DEVICE. 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-REDWOOD CITY 900356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention