BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2072871 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-02996
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS OF THE RETURNED COMPONENTS OF THE DEVICE, HANDLE TO FOOT FUNCTION, GUIDE TUBE, NEEDLE GUIDE, BRIDGE, SUTURE BEARING, EXIT RAMP AND SHEATH WERE NORMAL, THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY THAT WOULD CONTRIBUTE TO THE REPORTED SUTURE NOT HOLDING. POSSIBLE CAUSES FOR THE REPORTED EXPERIENCE INCLUDE, BUT NOT LIMITED TO, INCOMPLETE OR PARTIAL TISSUE CAPTURED INHIBITING FULL CLOSURE OF THE ARTERIOTOMY OR THE KNOT BEING TIGHTENED PREMATURELY ABOVE THE ARTERY. HOWEVER, THIS COULD NOT BE DETERMINED IN THIS CASE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION FINDINGS, THE CAUSE FOR THE REPORTED DIFFICULTY TIGHTENING OF THE SUTURE AT THE CLOSURE SITE COULD NOT BE DETERMINED. THE REPORTED DIFFICULTIES EXPERIENCED DURING THE PROCEDURE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED FOR DEVICE OPERATING DIFFERENTLY THAT EXPECTED FOR THE SUTURE. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT 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 PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE SUTURES WERE DEPLOYED, BLEEDING CONTINUED. MANUAL COMPRESSION WAS APPLIED FOR 10 MINUTES AND A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. IT WAS NOTED THAT THE SUTURES DID HOLD TIED AS DESIGNED; THERE WAS TOO MUCH LEAKAGE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 010446H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention