BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1961541 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00292
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION FOUND THE DEVICE IN PRE-PLUNGER DEPLOYMENT STATE WITH BLOOD PRESENT. THE SHEATH WAS KINKED DISTAL OF THE SUTURE BEARING. THE DAMAGE TO THE SHEATH IS CONSISTENT WITH DEVICE INSERTION AGAINST EXCESSIVE RESISTANCE CAUSING THE GUIDE TO KINK. DURING TESTING THE DEVICE WAS LOADED OVER A 0.035 INCH GUIDE WIRE WITHOUT DIFFICULTY, INDICATING GUIDE WIRE LOADING WAS NOT A CONTRIBUTING FACTOR IN THE EVENT. DURING TESTING WATER WAS INJECTED THRU THE MARK TUBE AND EXITED THE MARK PORT WITHOUT DIFFICULTY. BASED ON THE TEST RESULTS THE NO BLOOD RETURN/NO MARKING REPORT COULD NOT BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE DAMAGED SHEATH AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS IS RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. 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. WEIGHT: THE FACILITY REPORTER INDICATED THE PATIENT WEIGHT WAS (B)(6). 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 TECHNICIAN, TRAINED IN THE USE OF THE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SHEATH KINKED AND NO BLOOD RETURN/NO MARKING WAS OBTAINED. THE DEVICE WAS REMOVED FROM THE PATIENT'S ANATOMY AND A SECOND PROGLIDE WAS USED SUCCESSFULLY TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECT. 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 950086H

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention