BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3841004 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03466
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    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). A FEMORAL VENOUS SHEATH WAS REPORTED TO BE NEXT TO THE ARTERIAL SHEATH DURING CLOSING. PER THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE PROGLIDE DEVICE HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH IPSILATERAL FEMORAL VENOUS SHEATH DURING THE CATHETERIZATION PROCEDURE. 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 REPORT.

    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 FOR THIS LOT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR HEMOSTASIS REPORTED FROM THIS LOT. 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 SUTURE PLACEMENT WAS SUCCESSFUL WITH TWO PROGLIDE DEVICES IN THE RIGHT COMMON FEMORAL ARTERY USING THE PRECLOSE TECHNIQUE PRIOR TO A MITRAL VALVE REPAIR (LH CLOSURE). THE ARTERIOTOMY WAS A 6F AND THE SHEATH WAS ULTIMATELY UPSIZED TO AN 18F SHEATH FOR THE MITRAL VALVE REPAIR. REPORTEDLY, AFTER THE MITRAL VALVE REPAIR THE SUTURES WERE PULLED DOWN TO THE VESSEL TO ATTEMPT HEMOSTASIS, BUT WAS NOT ACHIEVED. THE KNOT PUSHER WAS USED BUT HEMOSTASIS STILL WAS NOT ACHIEVED. A VENOUS SHEATH WAS REPORTED TO BE NEXT TO THE ARTERIAL SHEATH DURING CLOSING. A CUT-DOWN PROCEDURE WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED USING A VASCULAR PATCH. DURING THE CUT-DOWN PROCEDURE IT WAS NOTED THAT THE SUTURES HAD NOT CAPTURED THE VENTRAL WALL OF THE VESSEL. BOTH SUTURES HAD CAPTURED THE INSIDE OF THE VESSEL DORSAL WALL RESULTING IN HEMOSTASIS NOT BEING ACHIEVED. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS IN-TRAINING IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318446 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 40228K1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F/8F/10F/12F/15F/18F, HEPARIN