BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2192056 · Received August 4, 2011

    Report

    Report Number
    2024168-2011-05509
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 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). 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 REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE WHOLE MONOFILAMENT WAS RETURNED LOOSE AND THERE WAS A KNOT FORMED WITH SOME TISSUE-LIKE MATERIAL STILL ATTACHED TO THE MONOFILAMENT. THIS IS CONSISTENT WITH SUCCESSFUL NEEDLE DEPLOYMENT AND SUTURE RETRIEVAL. BASED ON THE RESULTS OF THE INVESTIGATION, THE SUTURE WAS PULLED OUT FROM THE ARTERY, CONFIRMING THE REPORTED EXPERIENCE. POSSIBLE CONTRIBUTING FACTORS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. THE SUTURE WAS RETURNED INTACT WITH A PROPERLY FORMED AND TIGHTENED SUTURE KNOT. THERE WERE NO MANUFACTURING RELATED DEFICIENCIES DETECTED AND THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED. THE PROBABLE CAUSES FOR THE SUTURE BEING PULLED OUT OF THE ARTERY: INSUFFICIENT TISSUE CAPTURED, DEVICE DEPLOYED OUTSIDE THE ARTERY OR APPLICATION OF EXCESSIVE PRESSURE ON THE SUTURE WHILE ATTEMPTING TO ADVANCE THE KNOT. THEREFORE, THE PROBABLE CAUSE FOR THE REPORTED EVENT IS RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND 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 INSPECTION DURING MANUFACTURING AND A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE PROGLIDE DEVICE AFTER A DIAGNOSTIC PROCEDURE USING A 6F SHEATH. REPORTEDLY, WHILE ADVANCING THE KNOT, THE ENTIRE SUTURE PULLED OUT OF THE ARTERY WITH A PIECE OF TISSUE ATTACHED (4X4X4 MM). MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 30 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE. 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 060026H

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention SHEATH: 6F