BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2940887 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00590
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SAFETY AND EFFECTIVENESS OF THE PERCLOSE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT ACCESS SITE. IT IS INDICATED THAT THE DEVICE WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER 2 PROGLIDE DEVICES REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS ATTEMPTED BILATERALLY WITH THE PROGLIDE DEVICE IN THE RIGHT AND LEFT COMMON FEMORAL ARTERIES (RCFA AND LCFA) PRIOR TO AN ABDOMINAL AORTIC ANEURYSM REPAIR. ON THE RCFA, TWO PROGLIDES WERE DEPLOYED USING THE PRECLOSE TECHNIQUE AND THE SUTURES SET ASIDE UNEVENTFULLY. THE ARTERIOTOMY WAS A 7FR. THE SHEATH WAS UPSIZED TO 18 FR TO PERFORM THE INDEX PROCEDURE. THE RCFA WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. A 7 FR SHEATH WAS USED TO ACCESS THE LCFA WHICH WAS NON-TORTUOUS AND NOT CALCIFIED. REPORTEDLY, TWO PROGLIDES WERE ATTEMPTED, ONE AT A TIME, AND DURING PLUNGER RETRACTION THERE WAS NO SUTURE PRESENT ON THE NEEDLE. A THIRD AND FOURTH PROGLIDES WERE DEPLOYED AND SUTURES SET ASIDE TO PERFORM THE INDEX PROCEDURE. THE SHEATH WAS UPSIZED TO 22 FR TO PERFORM THE INDEX PROCEDURE. UPON COMPLETION OF THE INDEX PROCEDURE, THE DEPLOYED SUTURES IN THE RCFA CLOSED THE WOUND AND ACHIEVED HEMOSTASIS WITHOUT ISSUES. ON THE LCFA, BY PULLING ON THE BLUE RAIL SUTURE OF THE THIRD PROGLIDE, THE SUTURE WAS LOADED ON THE SUTURE TRIMMER AND THE KNOT WAS GENTLY ADVANCED BEFORE REMOVING THE GUIDE WIRE, BUT HEMOSTASIS COULD NOT BE ACHIEVED. THE PHYSICIAN FELT THERE WAS A PROBLEM WITH THE KNOT. THEREFORE, HE USED ONE MORE PROGLIDE (FIFTH). THE GUIDE WIRE WAS STILL IN PLACE AND THE KNOTS OF THE FOURTH AND FIFTH PROGLIDES WERE ADVANCED. HEMOSTASIS WAS ACHIEVED WITH THE SUTURES OF THE THIRD, FOURTH AND FIFTH PROGLIDES. THE GUIDE WIRE WAS REMOVED FROM THE GROIN ONCE HEMOSTASIS WAS ACHIEVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47207 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21011J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7 FR, 18 FR, 22 FRHEPARIN