BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1954658 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00186
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 21, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND A POSTERIOR CUFF MISS OCCURRED AS EVIDENCED BY THE POSTERIOR CUFF REMAINING IN THE FOOT POCKET. THE POSTERIOR NEEDLE TIP WAS RELEASED FROM THE SHANK BUT DID NOT ENGAGE WITH THE POSTERIOR CUFF AND REMAINED UNDAMAGED. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM THE POSTERIOR FOOT POCKET. BECAUSE THE POSTERIOR NEEDLE DID NOT ENGAGE WITH THE POSTERIOR CUFF, THE CUFF WAS NOT EJECTED FROM THE FOOT. WHEN THE PLUNGER WAS REMOVED FROM THE DEVICE, THE LINK WAS HELD ON ONE END BY THE POSTERIOR CUFF IN THE FOOT POCKET WHILE BEING PULLED ON THE OTHER END BY THE WITHDRAWAL OF THE PLUNGER. THIS RESULTED IN THE ANTERIOR CUFF DETACHING FROM THE NEEDLE AS INDICATED BY THE DAMAGED ANTERIOR NEEDLE AND ANTERIOR CUFF TABS. A POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF DETACHMENT WOULD RESULT IN A FAILURE TO RETRIEVE THE SUTURE DURING PLUNGER RETRACTION AND THIS COULD APPEAR VERY SIMILAR TO THE REPORTED EVENT. DURING TESTING, THE PLUNGER WAS REINSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS WERE ACCEPTABLE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR CUFF MISS AND SUBSEQUENT ANTERIOR CUFF-TO-NEEDLE TIP DETACHMENT IS NEEDLE DEFLECTION DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4). DEVICE #2 - PROGLIDE (PART #12673-03; LOT #940406H) WILL BE FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE USING A PRECLOSE TECHNIQUE IN THE COMMON FEMORAL ARTERY PRIOR TO AN INTERVENTIONAL PROCEDURE (IMPELLA INSERTION). REPORTEDLY, THE SUTURE DID NOT DEPLOY. THE VESSEL WAS REWIRED AND A SECOND PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS. HEMOSTASIS WAS ULTIMATELY ACHIEVED AFTER THE INTERVENTIONAL PROCEDURE USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention