BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2130464 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04236
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 SECOND PROGLIDE IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. WITHOUT THE PRODUCT TO EXAMINE, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED INCIDENT. A CUFF-MISS CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, FAILURE 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 CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), 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 COULD NOT 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 IS ALSO TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. REVIEW OF THE DEVICE LOT HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE WAS USED WITH THE SAME RESULTS. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 030336H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN