BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2080764 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03267
    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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT THE PLUNGER, SUTURE, LINK, NEEDLES, AND CUFFS WERE NOT RETURNED WITH THE DEVICE; THEREFORE, THE SCOPE OF THIS INVESTIGATION WAS VERY LIMITED. INSPECTION OF THE RETURNED DEVICE REVEALED NO NEEDLE STRIKE MARK AT THE POSTERIOR FOOT TO SUGGEST THAT THE POSTERIOR NEEDLE STRUCK THE FOOT INSTEAD OF ENGAGED WITH THE CUFF DURING NEEDLE DEPLOYMENT. ALSO, THERE WERE NO ABNORMAL OBSERVATIONS. DURING TESTING, THE PROXY PLUNGER WAS INSERTED TO TEST THE NEEDLE TRAJECTORY AND PUSH MANDREL TRAVEL AND THE RESULTS MET THE MANUFACTURING CRITERIA. THERE WAS NO OBSERVABLE RESISTANCE WHILE RETRACTING THE PROXY NEEDLE PLUNGER TO SUGGEST THAT A SUTURE BREAK, LINK DETACHMENT OR CUFF DETACHMENT MIGHT HAVE BEEN OCCURRED DURING THE SUTURE RETRIEVAL PROCESS. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN 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 020136H

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention