BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 17192016 · Received June 23, 2023

    Report

    Report Number
    2024168-2023-06674
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 30, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE MALPOSITION WAS CONFIRMED BASED ON RETURNED DEVICE CONDITION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR FRIABLE FEMORAL VESSEL DUE TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D4 - LOT # UPDATED FROM 2101842 TO 2110741 D4 EXPIRATION DATE AND H4 MANUFACTURING DATE CORRECTED AS A RESULT OF LOT NUMBER UPDATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE VIA A 8F SHEATH HOLE PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) INTERVENTIONAL PROCEDURE. THE SUTURES OF ONE PROGLIDE WERE SUCCESSFULLY PRE-PLACED. REPORTEDLY, WHEN AN ATTEMPT WAS MADE WITH A SECOND PROGLIDE DEVICE, THE SUTURE CAME OUT WITH THE DEVICE AFTER DEPLOYMENT WHEN HARVESTING THE SUTURES. THE SUTURES OF ANOTHER PROGLIDE DEVICE WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 12F SHEATH. THE EVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE TWO PRE-PLACED PROGLIDE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749451 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2110741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention PROGLIDE SUTURE