BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191672 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05487
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT IT WAS PARTIALLY DEPLOYED WITH PLUNGER, SUTURE, NEEDLES, AND CUFFS IN PRE-DEPLOYED POSITION, CONTRADICTING THE REPORTED PRODUCT EXPERIENCE. DRIED BLOOD WAS OBSERVED THROUGHOUT THE DEVICE, INDICATING THAT THE DEVICE HAD BEEN INTRODUCED INTO THE PATIENT ANATOMY. THE LINK WAS SLACK, SUGGESTING THAT THE FOOT MIGHT HAVE BEEN DEPLOYED. THERE WERE NO DAMAGES OBSERVED ON THE DEVICE. DURING LAB TESTING, THE LUMINAL MARKING TEST WAS PERFORMED AND THE RESULT MET THE MANUFACTURING CRITERIA. THE NEEDLES WERE NOT ABLE TO DEPLOYED DUE TO EXCESSIVE DRIED BLOOD INSIDE THE DEVICE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AS THE DEVICE WAS PARTIALLY DEPLOYED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC LEFT HEART CATHERIZATION THROUGH A 5F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, NO SUTURE WAS ATTACHED TO THE NEEDLE. THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 010266H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROCEDURAL SHEATH 5F