BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 5521775 · Received March 23, 2016

    Report

    Report Number
    2024168-2016-01876
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 23, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PARTIAL UDI IS BEING REPORTED AS THE SITE COULD NOT VERIFY THE LOT NUMBER OF THE INCIDENT DEVICE. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A REVIEW OF THE LOT HISTORY RECORDS FOR BOTH LOT NUMBERS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THESE LOTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT IN A COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE FOOT OF THE PROGLIDE DEVICE WAS DIFFICULT TO RETRACT. THREE ATTEMPTS AT CLOSING THE LEVER WERE MADE BEFORE THE FOOT SUCCESSFULLY CLOSED. THE LOT NUMBER OF THE PROGLIDE COULD NOT BE DETERMINED AND WAS EITHER LOT NUMBER 5100841 OR 5102141. THE SUTURES OF ANOTHER PROGLIDE DEVICE WERE SUCCESSFULLY PREPLACED USING THE PRE-CLOSE TECHNIQUE. THE SHEATH WAS UPSIZED TO 18F AND THE AAA PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE SUCCESSFULLY PREPLACED SUTURES OF THE REPORTED DEVICE AND THE SECOND DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE AND IN THE PRE-CLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177243 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1