BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2022724 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01800
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE PLUNGER WITH THE ANTERIOR NEEDLE TIP, SUTURE WITH THE POSTERIOR NEEDLE TIP, THE LINK AND THE CUFFS WERE NOT RETURNED. ANALYSIS FOUND THE BODY OF THE DEVICE, LEVER, FOOT, GUIDE AND SHEATH WITH NO DAMAGE DETECTED THAT WOULD CONTRIBUTE TO THE REPORTED NEEDLE TO CUFF MISS. BOTH ENDS OF THE FOOT WERE EXAMINED AND THERE WERE NO EVIDENCE OF NEEDLE STRIKE MARKS DETECTED. A PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND THE RESULTS WERE ACCEPTABLE. A CUFF MISS MAY OCCUR IF THE OPERATOR FAILS TO POSITION AND MAINTAIN THE DEVICE AT A 45 DEGREE ANGLE THROUGHOUT DEPLOYMENT, ROTATES THE DEVICE AT ANY POINT DURING PLUNGER/NEEDLE DEPLOYMENT, DEPLOYS THE DEVICE IN CHALLENGING ANATOMIES (E.G. HEAVY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.), AGGRESSIVELY DEPLOYS THE PLUNGER OR AGGRESSIVELY REMOVES THE PLUNGER, OR FAILS TO MAINTAIN ADEQUATE FOOT POSITION AGAINST THE ARTERIAL WALL. BASED ON THE ANALYSIS OF THE RETURNED COMPONENTS THE INCIDENT OF A NEEDLE TO CUFF MISS COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA.

    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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    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 COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS USED 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 950246H

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention