BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2821581 · Received November 6, 2012

    Report

    Report Number
    2024168-2012-06990
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. ESTIMATED DATE OF BIRTH (REPORTED AS 1956). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ACHIEVED USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, HOWEVER, THE PHYSICIAN HAD DIFFICULTY RE-INSERTING A .035 "J" GUIDE WIRE BACK INTO THE PROGLIDE DEVICE AFTER DEPLOYMENT OF THE SUTURES. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN WAS ABLE TO RE-INSERT THE GUIDE WIRE IN THE PROGLIDE DEVICE. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING THE PROGLIDE SUTURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20719J1

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR SHEATH: 6FGUIDE WIRE: J TIPANGIOMAX