BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191927 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05510
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS PARTIALLY DEPLOYED WITH EXCESSIVE DRIED BLOOD OBSERVED AT THE POSTERIOR NEEDLE SLOT, INDICATING THE DEVICE WAS INTRODUCED INTO THE PATIENT ANATOMY. THE LINK WAS SLACK, INDICATING THE FOOT WAS DEPLOYED. HOWEVER, THE PLUNGER, SUTURE, NEEDLES, AND CUFFS WERE IN PRE-DEPLOYED POSITION. HYDROPHILIC COATING WAS PRESENT THROUGHOUT THE SHEATH SURFACE AND THERE WAS NO INDICATION OF DIFFICULTY INTRODUCING THE DEVICE INTO THE PATIENT ANATOMY. THERE WAS NO INDICATION THAT A FAILURE TO ACHIEVE LUMINAL MARKING OCCURRED AS THE LUMINAL MARKING TEST WAS PERFORMED DURING TESTING AND THE RESULT MET THE MANUFACTURING CRITERIA. ADDITIONALLY, AFTER THE DEVICE WAS DECONTAMINATED, NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL WERE SUCCESSFUL AS INTENDED. BASED ON THE INVESTIGATION, THE DEVICE WAS FULLY FUNCTIONAL AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT REVEALED NO OTHER SIMILAR INCIDENTS. 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 DEVICE WAS 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 AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE PERCLOSE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A DEVICE FAILURE OCCURRED. ANOTHER PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE DEVICE. 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 020396H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SHEATH: 6FOTHER: HEPARIN