BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131968 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04281
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 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
    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 NOT RETURNED FOR ANALYSIS. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION CAN BE MADE AS TO THE CAUSE OF THE REPORTED DISCREPANCY. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, INABILITY TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATING THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYMENT IN A CHALLENGING ANATOMY, AGGRESSIVELY DEPLOYING OR REMOVING THE PLUNGER AND/OR INADEQUATE POSITIONING OF THE FOOT AGAINST THE ARTERIAL WALL. WHETHER THESE CONDITIONS PLAYED A ROLE IN THE EXPERIENCED EVENT CANNOT BE VERIFIED. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, IN-PROCESS TESTING OF DEVICES ARE PERFORMED TO ASSURE THE TRAJECTORY OF NEEDLES IN ORDER TO PREVENT THIS MODE OF FAILURE. IN ADDITION, A SAMPLING OF FINISHED DEVICES ARE TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY MANUFACTURING RELATED NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED. BASED ON THE INFORMATION AVAILABLE, THE INSPECTION CRITERIA AND THE REVIEW OF THE LOT HISTORY RECORD THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, A POSTERIOR CUFF MISS OCCURRED. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 030086H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention