BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 16755734 · Received April 17, 2023

    Report

    Report Number
    2024168-2023-03911
    Event Type
    Injury
    Date Received
    April 17, 2023
    Date of Event
    February 6, 2023
    Report Date
    July 18, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS OBSERVED AS A LINK BREAK. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR LINK PULLED UNTIL IT BREAKS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. D4: LOT NUMBER UPDATED FROM 2053141 TO 2030241. D4: EXPIRATION DATE. H4: MANUFACTURING DATE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: HEMOSTASIS WAS ACHIEVED WITH A NEW PROGLIDE DEVICE, NO MANUAL COMPRESSION AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE AFTER A SUPERFICIAL FEMORAL ARTERY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, A CUFF MISS [SUTURE RETRIEVAL ISSUE] OCCURRED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. 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
    2321817 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 2030241

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention