BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2082369 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03325
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE ANTERIOR CUFF IN THE FOOT POCKET WITH ITS TABS INTACT. THE POSTERIOR CUFF WAS ATTACHED TO THE NEEDLE TIP, THE COMPLETE SUTURE WAS ALSO ATTACHED WITH THE LINK. THE ANTERIOR CUFF REMAINING IN THE FOOT POCKET AFTER DEPLOYMENT IS CONSISTENT WITH AND CONFIRMS THE REPORTED EXPERIENCE OF NEEDLE CUFF MISS. THIS FINDING INDICATES THE NEEDLE WAS DEFLECTED OUTSIDE OF THE FOOT POCKET. A NEEDLE TO CUFF MISS OCCURS WHEN 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. DURING TESTING, A PROXY PLUNGER WAS INSERTED INTO THE DEVICE AND THE NEEDLE TRAJECTORY WAS ACCEPTABLE INDICATING THE NEEDLES WERE NOT A CONTRIBUTING FACTOR IN THE EVENT. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED CUFF MISS EXPERIENCED DURING THE PROCEDURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY PROBLEM. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE FIRST AND SECOND PROGLIDE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE DEVICE HAS BEEN 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 AN UNSPECIFIED PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. A SECOND AND THIRD PROGLIDE DEVICE WERE USED WITH THE SAME RESULTS. A NON-ABBOTT 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 020106H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention