BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1936134 · Received December 22, 2010

    Report

    Report Number
    2953144-2010-03343
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AV-REDWOOD CITY
    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). EVALUATION OF THE RETURNED DEVICE FOUND IT IN THE PRE-PLUNGER DEPLOYMENT POSITION WITH BLOOD PRESENT IN THE DEVICE. DURING TESTING, A SOLUTION OF WATER WAS INJECTED INTO THE MARK TUBE AND EXITED THROUGH THE MARKER PORT WITHOUT DIFFICULTY. DURING TESTING, THE DEVICE FUNCTION ACCORDING TO SPECIFICATIONS AND ACHIEVED COMPLETE DEPLOYMENT. BASED ON THE SUCCESSFUL MARKING DURING TESTING AND THE CONDITION OF THE DEVICE, THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE FAILURE TO MARK DURING DEPLOYMENT IS RELATED TO USER TECHNIQUE OR PROCEDURE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    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, BLOOD FLOW WAS NOT ACHIEVED THROUGH THE MARKER LUMEN. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO PATIENT EFFECTS 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-REDWOOD CITY 930076H

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention