BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3011579 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01586
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNING IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT 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 SUTURE PLACEMENT WAS ATTEMPTED USING THE PROGLIDE DEVICE IN THE LEFT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN ABDOMINAL AORTIC ANEURYSM (AAA) INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS AN 6F. REPORTEDLY, IT WAS NOT POSSIBLE TO FLUSH THE MARKER LUMEN OF THE SYSTEM ON THE FIRST TRY, BUT ON A SECOND TRY THE MARKER LUMEN WAS FLUSHED SUCCESSFULLY. THE PROGLIDE WAS DEPLOYED, BUT NO SUTURES WERE VISIBLE. A SECOND PROGLIDE DEVICE WAS PLACED AT A 90 DEGREE ANGLE TO SUCCESSFULLY PRE-PLACE THE SUTURE. THE SHEATH WAS UPSIZED TO A 10F AND THE INDEX PROCEDURE WAS PERFORMED SUCCESSFULLY. HEMOSTASIS WAS ACHIEVED USING THE PRE-PLACED SUTURE OF THE SECOND PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS ALSO ACCESSED; IT WAS A SMALLER ACCESS AND CLOSED BY MANUAL ARTERIAL COMPRESSION. NO VESSEL CLOSURE DEVICE WAS TO BE USED FOR THE RCFA ARTERIOTOMY CLOSURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114617 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 20511J1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F, 10F, HEPARIN