BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131289 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04244
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED COMPONENTS BODY OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED DEVICE FAILURE. BOTH ENDS OF THE FOOT WERE ALSO EXAMINED AND THERE WERE NO NEEDLE STRIKE MARKS DETECTED. DURING TESTING A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. THE NEEDLE TRAJECTORY OF EACH DEVICE IS INSPECTED DURING MANUFACTURING. BASED ON THE ANALYSIS OF THE DEVICE AND THE INSPECTION CRITERIA THE REPORTED UNSPECIFIED FAILURE EXPERIENCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED. A REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AN UNKNOWN DEVICE FAILURE OCCURRED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 920516H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention