BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3895426 · Received June 25, 2014

    Report

    Report Number
    2024168-2014-04114
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE TWO OTHER PERCLOSE PROGLIDE DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH MFR NUMBERS.

    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 CANNOT 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 THAT ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO AN ENDOVASCULAR REPAIR STENTING PROCEDURE. THE SHEATH WAS UPSIZED TO 16F AND THE ENDOVASCULAR REPAIR STENTING PROCEDURE WAS COMPLETED. REPORTEDLY, THE SUTURE BROKE DURING KNOT ADVANCEMENT WITH BOTH PRE-PLACED SUTURES. TWO ADDITIONAL PROGLIDE DEVICES WERE USED TO ACHIEVE HEMOSTASIS. ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH TWO PROGLIDE DEVICES, USING A PRE-CLOSE TECHNIQUE, VIA A 6F SHEATH PRIOR TO THE ENDOVASCULAR REPAIR STENTING PROCEDURE. THE SHEATH WAS UPSIZED TO 12F. REPORTEDLY, ONE SUTURE BROKE DURING KNOT ADVANCEMENT. ONE ADDITIONAL PROGLIDE DEVICE AND THE OTHER PRE-PLACED PROGLIDE SUTURE WERE USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370153 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21010J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 12F, 16F