BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2080742 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03266
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT THE PLUNGER, ANTERIOR NEEDLE, LINK AND CUFFS WERE NOT RETURNED WITH THE DEVICE; THEREFORE, THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE POSTERIOR CUFF MISS HAD OCCURRED AS EVIDENCED BY DAMAGED POSTERIOR NEEDLE TIP. THERE WAS NO NEEDLE STRIKE MARK OBSERVED AT THE POSTERIOR FOOT. THIS IS INDICATIVE OF THE POSTERIOR NEEDLE BEING DEFLECTED AWAY FROM POSTERIOR FOOT AND INTERACTED WITH HUMAN TISSUE INSTEAD OF ENGAGED WITH THE POSTERIOR CUFF INSIDE THE POSTERIOR FOOT POCKET DURING NEEDLE DEPLOYMENT AS DESIGNED. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. BASED ON THE SUCCESSFUL TEST OF THE DEVICES, THE PROBABLE CAUSE FOR THE POSTERIOR CUFF MISS IS NEEDLE DEFLECTION DURING PLUNGER DEPLOYMENT DUE TO INTERACTION WITH HUMAN TISSUE OR A FAILURE TO MAINTAIN A STABLE POSITION OF THE DEVICE WITH RESPECT TO THE TISSUE TRACT AS SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. OVERALL, 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. ESTIMATED DATE (REPORTED AS OCCURRING 2-3 WEEKS AGO). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN UNKNOWN IF TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE PRODUCT EXPERIENCE THAT OCCURRED IS UNKNOWN. THE METHOD OF ACHIEVING HEMOSTASIS IS UNSPECIFIED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 020226H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention