BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191679 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05495
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND THERE WAS A KNOT FORMED. THIS IS CONSISTENT WITH SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE SUTURE WAS PULLED OUT FROM THE ARTERY. THE PROBABLE CAUSE FOR THE SUTURE PULLED OUT OF THE ARTERY IS NOT ENOUGH TISSUE CAPTURES OR THE DEVICE WAS DEPLOYED OUTSIDE THE ARTERY. THERE WERE NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE FAILURE MODE FOR THIS COMPLAINT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE PROBABLE ROOT CAUSE FOR THE SUTURE PULLED OUT OF THE ARTERY IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% 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 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 AFTER A DIAGNOSTIC PERCUTANEOUS CATHETERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PERCLOSE PROGLIDE DEVICE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED FROM THE BODY OF THE DEVICE, THE ENTIRE SUTURE WITH THE KNOT INTACT PULLED OUT FROM THE VESSEL. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE 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 960256H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROCEDURAL SHEATH 6F