BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3840863 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03459
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. IT WAS REPORTED THAT CALCIFICATION WAS NOTED IN THE COMMON FEMORAL ARTERY. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH FEMORAL ARTERY CALCIUM WHICH IS FLUOROSCOPICALLY VISIBLE AT THE ACCESS SITE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER PROGLIDE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUFF MISSES OCCURRED DURING SUTURE PLACEMENT WITH TWO PROGLIDE DEVICES IN A CALCIFIED COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO AN AORTIC VALVE INTERVENTIONAL PROCEDURE. THE ARTERIOTOMY WAS 5F AND UPSIZED TO A 12F FOR THE INTERVENTIONAL PROCEDURE. REPORTEDLY, THE FIRST PROGLIDE SUTURE WAS DEPLOYED AND A CUFF MISS OCCURRED. A SECOND PROGLIDE DEVICE WAS DEPLOYED SUCCESSFULLY. A THIRD PROGLIDE DEVICE WAS USED WITH THE SAME RESULTS AS THE FIRST PROGLIDE, A CUFF MISS OCCURRED. A FOURTH PROGLIDE DEVICE WAS SUCCESSFULLY DEPLOYED. THE INTERVENTIONAL PROCEDURE WAS COMPLETED AND HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED SUTURES OF THE TWO PROGLIDE DEVICES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE AND ESTABLISHED IN THE PRECLOSE TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318281 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40205K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 5F, 12F, HEPARIN