BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2830278 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07148
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE PLUNGER, LINK, NEEDLES AND CUFFS WERE NOT RETURNED, AND THE REPORTED CUFF MISS COULD NOT BE CONFIRMED. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE RAIL SUTURE END WAS CUT WITH THE DEVICE CUTTER. THIS IS CONSISTENT WITH SUCCESSFUL SUTURE RETRIEVAL DURING THE PLUNGER RETRACTION, INDICATING BOTH CUFFS HAD SUCCESSFULLY ENGAGED WITH THE NEEDLES DURING NEEDLE DEPLOYMENT. ANALYSIS ALSO INDICATED THAT THE SUTURE KNOT WAS BROKEN; HOWEVER, THE RAIL SUTURE PARTIALLY REMAINED INSIDE THE DEVICE. THE OBSERVED DAMAGE IS CONSISTENT WITH THE KNOT BEING BROKEN DURING THE DEVICE REMOVAL RATHER THAN KNOT ADVANCEMENT. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE WITH A 6FR SHEATH, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. 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 20830J1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention GUIDE WIRE: 0.35SHEATH: 6 FR HEPARIN