BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2131864 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04275
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT THE BODY OF THE DEVICE WAS OPENED UP AT THE PROXIMAL END EXPOSING THE LEVER WHICH IS CONSISTENT WITH THE REPORTED INCIDENT. THE POSTERIOR FOOT WAS EXAMINED AND THERE WAS NO EVIDENCE OF FOOT SURFING, WHICH WOULD SHOW IF THE FOOT CAUGHT SOME TISSUE DURING FOOT PARKING AND WOULD PREVENT THE FOOT FROM PARKING PROPERLY. IF THE FOOT IS NOT SEATED PROPERLY INSIDE THE GUIDE, THIS COULD ALSO LEAD TO A DIFFICULT DEVICE REMOVAL. DURING THE INVESTIGATION, THE DEVICE WAS DISASSEMBLED AND THE FOOT WAS MANUALLY PARKED AND UN-PARKED WITHOUT A PROBLEM. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED ABOVE THE PELVIC RIM. WHETHER THIS CONTRIBUTED TO THE EVENT EXPERIENCE COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE WERE NO OTHER REPORTED DIFFICULT TO REMOVE DEVICE AND FOOT RETRACTION PROBLEM WITHIN THIS LOT. THERE WERE NO MANUFACTURING OR QUALITY DEFICIENCY DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN USING THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF ABOVE THE PELVIC RIM, AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN PULLING THE PLUNGER BACK THE LEVER FELT LOOSE, THE FOOT WOULD NOT RETRACT AND THE DEVICE COULD NOT BE REMOVED FROM THE PATIENT. THE FOOT WAS REDEPLOYED AND A SECOND ATTEMPT WAS MADE TO RETRACT THE FOOT BUT WAS UNSUCCESSFUL. THE PATIENT EXPERIENCED PAIN AS THE DEVICE WAS TRYING TO BE REMOVED. THE DEVICE WAS THEN BROKE APART AND THE FOOT WAS MANUALLY RETRACTED SO THE DEVICE COULD BE REMOVED FROM THE ANATOMY. THE DEVICE ACHIEVED HEMOSTASIS; HOWEVER, THERE WAS OOZING WHICH WAS TREATED WITH ADJUNCTIVE COMPRESSION. 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 030126H

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention HEPARIN| SHEATH: 6 FR