BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2895318 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00031
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: DURING THE CLOSURE PROCEDURE, A VENOUS SHEATH WAS NOT NEXT TO THE ARTERIAL SHEATH. THERE WAS NO PROBLEM DEPLOYING THE PROGLIDE DEVICE. AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT REPORTEDLY FOLLOWED THE AFTERCARE INSTRUCTIONS BY AVOIDING BATHING IN A BATHTUB OR POOL FOR FIVE DAYS AFTER THE PROCEDURE. ONE WEEK LATER THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR TWO WEEKS FOR INFECTION WITH REDNESS AND SWELLING AT THE GROIN SITE AND WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED PROCEDURE, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY (CFA) WAS SUCCESSFULLY ACHIEVED USING A PERCLOSE PROGLIDE DEVICE. ONE WEEK POST-PROCEDURE THE PATIENT DEVELOPED AN INFECTION OF THE CFA, WHICH WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. REPORTEDLY, THERE WERE NO ISSUES DURING PUNCTURE OF THE GROIN AND AFTER COMPLETION OF THE UNSPECIFIED PROCEDURE AND BEFORE ARTERIOTOMY CLOSURE, THE OPERATOR CHANGED GLOVES, REPREPPED THE GROIN, USED A NEW DRAPE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3760 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SHEATH: 6-FRENCH