BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2080757 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03258
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 12, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION OF THE RETURNED DEVICE FOUND THAT THE PLUNGER, SUTURE, NEEDLES, AND CUFFS WERE IN THE PRE-DEPLOYED POSITION; HOWEVER, THE LINK WAS SLACK, INDICATING THE FOOT WAS DEPLOYED. DURING TESTING, THE LUMINAL MARKING TEST WAS PERFORMED AND THE RESULT WAS UNSUCCESSFUL AS REPORTED. THE DEVICE WAS DISASSEMBLED FOR INTERNAL INSPECTION AND FOUND EXCESSIVE DRIED BLOOD OCCLUDING THE INNER MARKER LUMEN TUBE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR A FAILURE TO ACHIEVE LUMINAL BLOOD MARKING IS DUE TO A BLOOD CLOT OR OTHER BIOLOGICAL MATTERS. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH EITHER REPORTED OR CONFIRMED FAILURE TO ACHIEVE LUMINAL BLOOD MARKING DURING THE DEVICE INTRODUCTION. REVIEW OF THE DEVICE HISTORY LOT RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL, RELEVANT INFORMATION.

    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 RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THERE WAS NO BLOOD FLOW IN THE MARKER LUMEN. SEVERAL ATTEMPTS WERE MADE BUT NO PATENCY WAS ACHIEVED. A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. 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 940406H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention