BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2183074 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05374
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. WITHOUT DEVICE EVALUATION, A CAUSE FOR THE REPORTED CUFF MISS COULD NOT BE DETERMINED. A CUFF MISS CAN BE INFLUENCED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, THE INABILITY TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL OR PATIENT ANATOMY. AS THE NEEDLE TRAJECTORY CAN BE A CONTRIBUTOR TO A CUFF MISS, IT IS CHECKED DURING MANUFACTURING. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN REVIEW OF THE AVAILABLE INFORMATION, TEST CRITERIA AND DATABASE QUERIES, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND DEVICE WAS USED WITH THE SAME RESULTS. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. REPORTEDLY, THE PHYSICIAN IS TRAINED IN THE USE OF THE DEVICE. 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 030266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX