BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2024215 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01837
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 22, 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
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED A NEEDLE STRIKE MARK AT THE POSTERIOR FOOT AND A BENT POSTERIOR NEEDLE TIP. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE STRIKING THE POSTERIOR FOOT DURING NEEDLE DEPLOYMENT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET AS DESIGNED. 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 DAMAGED ANTERIOR NEEDLE BARB. HOWEVER, A LINK AND BOTH CUFFS WERE NOT RETURNED WITH THE DEVICE. THE RETURNED NEEDLE FOLLOWERS WERE BENT, CONSISTENT WITH POST-PROCEDURE SHIPPING/MISHANDLING DAMAGE. DURING TESTING, THE PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL LENGTH AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE SUCCESSFUL TEST OF THE DEVICES NEEDLE TRAJECTORY IN THE LAB AND TESTING DURING MANUFACTURING, THE PROBABLE ROOT CAUSE FOR THE POSTERIOR NEEDLE STRIKING THE FOOT INSTEAD OF ENGAGING WITH THE POSTERIOR CUFF, RESULTING IN 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(6). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL 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 RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED AND A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. 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 960206H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention