BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2090308 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03496
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    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
    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. ESTIMATED AGE (REPORTED AS APPROXIMATELY (B)(6)). THE 2 PERCLOSE PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE WAS REPORTED AS BEING DISCARDED. A CUFF MISS (NO SUTURE RETRIEVED/ATTACHED) CAN OCCUR DUE TO A NUMBER OF FACTORS INCLUDING, BUT NOT LIMITED TO, NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT BECAUSE OF INTERACTION WITH HUMAN TISSUE, AGGRESSIVE AND FAST DEPLOYMENT OF THE PLUNGER OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT DURING NEEDLE DEPLOYMENT. THIS MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS EVENT, BUT CANNOT BE CONFIRMED. ULTIMATELY, THE RETURN OF THE DEVICE MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED EVENT. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A IN PROCESS TESTING OF DEVICES IS PERFORMED TO ASSURE THERE IS NO NEEDLE DEFLECTION, WHICH MAY CAUSE THE EVENT REPORTED IN THIS CASE. A SAMPLING OF FINISHED DEVICES IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY ASSOCIATED WITH THIS EVENT. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED EXPERIENCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICES ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PRECLOSE TECHNIQUE BEFORE AN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR). REPORTEDLY, THREE PROGLIDES WERE DEPLOYED SUCCESSFULLY: 2 FOR THE OTHER GROIN AND 1 FOR THE WORKING GROIN. WHEN ANOTHER PROGLIDE WAS BEING DEPLOYED IN THE WORKING GROIN, THE NEEDLE DEPLOYMENT WENT SMOOTHLY, BUT WHEN THE PLUNGER WAS BEING REMOVED FROM THE DEVICE, THE SUTURE WAS NOT ATTACHED. TWO ADDITIONAL PROGLIDES WERE USED WITH THE SAME RESULTS. THE PHYSICIAN LOST CONFIDENCE IN THE DEVICE AND AFTER THE EVAR PROCEDURE, HEMOSTASIS WAS ACHIEVED SURGICALLY. THE PATIENT WAS REPORTED TO HAVE LOST 900CC OF BLOOD AND WAS TREATED WITH A BLOOD TRANSFUSION. AFTER THE PROCEDURE, WHILE EXAMINING THE SUTURE ON ONE OF THE DEVICES, THE SUTURE WAS DESCRIBED AS LOOKING LIKE IT HAD COMPLETELY UNRAVELED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. 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 010366H

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention