BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2840902 · Received November 20, 2012

    Report

    Report Number
    2024168-2012-07358
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 31, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; 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. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE SIX OTHER PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE, ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING SEVEN PERCLOSE PROGLIDE DEVICES. REPORTEDLY, DURING DEPLOYMENT, AN UNSPECIFIED MALFUNCTION OCCURRED WITH SEVEN PROGLIDE DEVICES SEQUENTIALLY. AN EIGHTH PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE OPERATOR WAS NOT SPECIFIED; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF THE OPERATOR COMPLETED TRAINING IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: DURING ATTEMPTS TO OBTAIN FURTHER DETAILS OF THE REPORTED EXPERIENCE THE CUSTOMER WAS UNABLE TO CONFIRM ANY INCIDENTS REPORTED INVOLVING PERCLOSE PROGLIDE DEVICES. 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 20924J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention