BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1982085 · Received February 8, 2011

    Report

    Report Number
    2024168-2011-00772
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    November 2, 2010
    Report Date
    January 18, 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). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER, CUFFS, LINK, NEEDLE TIP AND MONOFILAMENT WERE NOT RETURNED. WITHOUT THE RETURN OF THE MONOFILAMENT, WHICH IS AN INTEGRAL PART OF THIS INVESTIGATION, WE WERE UNABLE TO DETERMINE THE CAUSE OR CONFIRM THE REPORTED EVENT. THERE WAS NO ABNORMAL OBSERVATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT FROM INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT, ALTHOUGH THE EXACT CAUSE COULD NOT BE CONFIRMED. 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 USING THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SUTURE KNOT DID NOT SECURE FOR COMPLETE CLOSURE. MANUAL COMPRESSION WAS APPLIED FOR 57 MINUTES TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE 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-TEMECULA-CT 930396H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention