BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18136376 · Received November 14, 2023

    Report

    Report Number
    2024168-2023-12652
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 24, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED ¿SUTURE WAS NOT CONNECTED TO THE NEEDLE WHEN THE PLUNGER WAS PULLED OUT¿ WAS CONFIRMED AS A CUFF MISS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTY AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT 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 3050841 TO: 3010442.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE. REPORTEDLY, THE NEEDLE HANDLE [PLUNGER] WAS PRESSED IN AND ONLY THE WHITE THREAD [LINK] WAS ATTACHED. WHEN THE PLUNGER WAS PULLED OUT, THE SUTURE WAS NOT CONNECTED TO THE NEEDLE. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO LESS THAN 25F, AND THE TAVI PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURES. THERE WAS NO 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
    299633 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3010442

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention