BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2851343 · Received November 29, 2012

    Report

    Report Number
    2024168-2012-07552
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED POSTERIOR FOOT BREAK WAS CONFIRMED. THE RESULTANT NEEDLE-TO-CUFF MISS MAY HAVE BEEN DUE TO THE POSTERIOR FOOT BREAK. SINCE SOME DEVICE COMPONENTS WERE NOT RETURNED, ANALYSIS WAS LIMITED AND THE NEEDLE-TO-CUFF MISS COULD NOT BE CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY USING A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE DEVICE WAS REMOVED THE POSTERIOR PORTION OF THE FOOT WAS MISSING AND COULD NOT BE LOCATED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS MONITORED FOR FORTY-EIGHT HOURS FOR POSSIBLE EFFECTS OF THE DETACHED POSTERIOR PORTION OF THE FOOT, BUT DID NOT DEVELOP ANY EFFECTS. THE PATIENT WAS DISCHARGED AS PLANNED AS HOSPITALIZATION WAS NOT EXTENDED. THE PHYSICIAN REPORTEDLY MONITORS ALL PATIENTS FOR FORTY-EIGHT HOURS AFTER ALL INTERVENTIONAL PROCEDURES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE 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 20928J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6-FRENCH