BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2251211 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06354
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE REPORTED EVENT. A KINKED SHEATH CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, A MANUFACTURING DEFICIENCY, USER TECHNIQUE OR PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, DEVICES ARE VISUALLY INSPECTED AND A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. THE DEVICE SHEATH MAY KINK IF THE USER AGGRESSIVELY ADVANCES IT INTO PATIENT ANATOMY, OR IF IT IS USED IN AN OBESE PATIENT, OR IN HEAVILY SCARRED TISSUE. AS THERE IS LIMITED REPORTED INFORMATION ABOUT EVENT CIRCUMSTANCES, A CONCLUSIVE CAUSE FOR THE REPORTED KINKED SHEATH COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE DOES NOT APPEAR TO BE A LOT SPECIFIC PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE OTHER PERCLOSE PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, KINKING OCCURRED AND THE DEVICE COULD NOT BE BENT INTO THE ARTERY. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. A 6FR SHEATH WAS USED DURING INSERTION OF THE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. 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 060476H

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SHEATH: 6FRANGIOMAX