BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3843646 · Received June 2, 2014

    Report

    Report Number
    2024168-2014-03521
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(6). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE TWO OTHER PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE, PRECLOSE PLACEMENT OF THE SUTURES WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY (RCFA) AND THE LEFT COMMON FEMORAL ARTERY (LCFA) USING THE PROGLIDE DEVICE. THE RCFA ARTERIOTOMY WAS 7F. THE SHEATH WAS UPSIZED TO 12F FOR THE AAA PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. THE SUTURE OF ANOTHER PROGLIDE DEVICE WAS PREPLACED USING THE PRECLOSE TECHNIQUE. AFTER THE PROCEDURE, TWO PREPLACED SUTURES ACHIEVED HEMOSTASIS. REPORTEDLY, PRIOR TO THE AAA PROCEDURE DURING PREPLACEMENT OF THE SUTURE USING THE PRECLOSE TECHNIQUE IN THE LCFA, IT WAS OBSERVED THAT THE SUTURE WAS PULLED OUT LONGER THAN USUAL AND THE DEVICE WAS NOT USED. A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULT. THE SUTURE OF A THIRD PROGLIDE DEVICE WAS PREPLACED USING THE PRECLOSE TECHNIQUE. THE ARTERIOTOMY WAS 7F. THE SHEATH SIZE WAS UPSIZED TO 12F AND THEN TO 18F FOR THE AAA PROCEDURE. AFTER THE AAA PROCEDURE WAS COMPLETED, TWO SUCCESSFULLY PREPLACED SUTURES ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRE-CLOSE DEPLOYMENT TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322035 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40121K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F, 12F, 18F, HEPARIN