BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2080738 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03260
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE KNOT WAS PROPERLY FORMED AND THE RAIL SUTURE END WAS CUT. THIS IS CONSISTENT WITH SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. THERE WAS NO DRIED BLOOD OBSERVED ON THE RETURNED SUTURE AND NO TISSUE ATTACHED TO THE LOOP OR KNOT. THIS SUGGESTED THAT THERE MIGHT BE INSUFFICIENT TISSUE CAPTURED, EXCESSIVE PRESSURE APPLIED ON THE SUTURE WHILE ATTEMPTING TO ADVANCE THE KNOT OR THE DEVICE MIGHT HAVE BEEN DEPLOYED OUTSIDE THE ARTERY. THEREFORE, THE PROBABLE CAUSE FOR THE SUTURE BEING PULLED OUT OF THE ARTERY IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH SIMILAR REPORTED PRODUCT EXPERIENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONALLY UNUSED STERILE DEVICES FOR LOT 020226H(9), WERE RETURNED FOR EVALUATION. ALSO RETURNED, WERE STERILE DEVICES WITH LOT NUMBERS: 020046H(1), 010446H(3), 950246H(1). ALL THE RETURNED STERILE DEVICES WERE FUNCTIONALLY TESTED AND THE RESULTS MET THE MANUFACTURING CRITERIA. NEEDLE DEPLOYMENT, SUTURE RETRIEVAL, AND KNOT ADVANCEMENT WERE ALL SUCCESSFUL. CLOSURE OF THE PUNCTURE SITE WAS ACHIEVED ON TISSUE MODEL. BASED ON OUR INVESTIGATION, THE RETURNED STERILE DEVICES PERFORMED ACCORDING TO SPECIFICATIONS AND A CAUSE RELATED TO THE RETURNED STERILE DEVICES COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY 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 WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED WHICH STATES: REPORTEDLY, AFTER NEEDLE DEPLOYMENT AND PLUNGER REMOVAL, WHILE PULLING THE SUTURES TO ATTEMPT ADVANCING AND TIGHTENING THE KNOT, WHOLE SUTURE WAS PULLED OUT OF THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER NEEDLE DEPLOYMENT, WHILE RETRIEVING THE SUTURE, THE WHOLE SUTURE PULLED OUT OF THE ARTERY. A NON- ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 020226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention