BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2191223 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05479
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROGLIDE DEVICE REVEALED THAT THE NEEDLE PLUNGER, LINK, ANTERIOR NEEDLE, POSTERIOR NEEDLE, ANTERIOR CUFF, AND POSTERIOR CUFF WERE NOT RETURNED WITH THE DEVICE, WHICH LIMITED THE SCOPE OF THE INVESTIGATION. THE SUTURE WAS RETURNED CUT AT THE RAIL-END WITH THE DEVICE CUTTER AND THE KNOT WAS PROPERLY FORMED. THIS IS INDICATIVE OF SUCCESSFUL SUTURE RETRIEVAL DURING NEEDLE PLUNGER REMOVAL, WHICH CONTRADICTED THE REPORTED INFORMATION THAT THE ENTIRE SUTURE WITH THE KNOT INTACT CAME OUT WITH THE NEEDLE PLUNGER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT DURING NEEDLE DEPLOYMENT, THE NEEDLE PLUNGER WAS NOT FULLY DEPRESSED. WHEN THE NEEDLE PLUNGER WAS REMOVED, THE ENTIRE SUTURE WITH THE KNOT INTACT CAME OUT WITH THE DEVICE. HOWEVER, THIS COULD NOT BE CONFIRMED BECAUSE THE NEEDLE PLUNGER WAS NOT RETURNED WITH THE DEVICE. INSPECTION OF THE RETURNED SUTURE INDICATED THAT IT WAS PULLED OUT OF THE ARTERY WHILE ADVANCING AND JUST PRIOR TO TIGHTENING THE SUTURE KNOT TO CLOSE THE VESSEL. POSSIBLE CONTRIBUTING FACTORS FOR THE SUTURE BEING PULLED OUT OF THE ARTERY DURING THE KNOT ADVANCEMENT/TENSIONING INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. HOWEVER, THE SUTURE WAS RETURNED INTACT WITH PROPERLY FORMED SUTURE KNOT. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED WHICH COULD HAVE CONTRIBUTED TO THE SUTURE BEING PULLED OUT OF THE ARTERY. APPLYING EXCESSIVE PRESSURE TO THE SUTURE DURING THE KNOT DELIVERY/TENSIONING COULD HAVE CAUSED THE SUTURE LOOP TO BE PULLED OUT OF THE ARTERY AS DETECTED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR PULLING THE SUTURE OUT OF THE ARTERY IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED AS EXCESSIVE PRESSURE WAS APPLIED TO THE SUTURE. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED AS A RESULT OF THIS INVESTIGATION. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO NONCONFORMING MATERIAL RECORD ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND FOUND NO 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. A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY FUNCTIONALITY OF THE DEVICE.

    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 AFTER A DIAGNOSTIC PERIPHERAL CATHERIZATION 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 TO HARVEST THE SUTURE, THE ENTIRE SUTURE WITH THE KNOT INTACT CAME OUT WITH THE NEEDLE PLUNGER. THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE OPERATOR WAS REPORTED TO BE TRAINED IN THE USE OF THE PERCLOSE 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 060026H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention PROCEDURAL SHEATH 6F