BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2233574 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06144
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WAS NO DAMAGE OR MANUFACTURING/QUALITY DEFICIENCY OBSERVED ON THE RETURNED DEVICE. THEREFORE, BASED ON THE UNSPECIFIED DEVICE ISSUE INFORMATION REPORTED AND OUR INVESTIGATION, A CAUSE FOR THE DEVICE NOT PERFORMING AS INTENDED COULD NOT BE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO SIMILAR UNSPECIFIED INCIDENTS AND 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. DATE OF EVENT: THE FACILITY REPORTER HAD NO INFORMATION WHEN THE EVENT OCCURRED. THE MANUFACTURER REPRESENTATIVE BECAME AWARE OF THE EVENT ON (B)(6) 2011. THE DATE OF (B)(6) 2011 IS BEING USED AS THE BEST ESTIMATED DATE. 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 A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AN UNSPECIFIED DEVICE FAILURE OCCURRED AND HEMOSTASIS WAS ACHIEVED USING AN UNSPECIFIED METHOD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PHYSICIAN IS TRAINED IN THE USE OF THE PROGLIDE DEVICE. THOUGH REQUESTED, 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 060226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention