BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 18916235 · Received March 15, 2024

    Report

    Report Number
    2024168-2024-03383
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    January 29, 2024
    Report Date
    May 20, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648113154
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE ADDITIONAL PROGLIDE DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. NA.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INSUFFICIENT INFORMATION WAS OBSERVED AS SUTURE RETRIEVAL ISSUE NEEDLE TO CUFF MISS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED DIFFICULTIES 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. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTIONS: D4 - LOT # UPDATED FROM 3041843 TO 3041941. H4 - DEVICE MFG DATE: UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A CLOSURE OF AN UNSPECIFIED VESSEL USING THE PRE-CLOSE TECHNIQUE PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE. REPORTEDLY, THE "SUTURES DID NOT WORK" WITH TWO PROGLIDE DEVICES. THE SUTURES OF TWO NEW PROGLIDE DEVICES WERE SUCCESSFULLY PRE-PLACED. THE SURGICAL PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR REPORT, RETURNED DEVICE ANALYSIS OF THE FIRST PROGILDE FOUND THAT THE POSTERIOR NEEDLE TIP WAS SEPARATED AND NOT RETURNED. ANALYSIS OF THE SECOND PROGLIDE DEVICE FOUND THAT THE POSTERIOR NEEDLE TIP WAS EJECTED FROM THE POSTERIOR NEEDLE SHANK WITH NO DAMAGES NOTED. THE ANTERIOR NEEDLE BARB WAS SCRATCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410601 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 3041941 08717648113154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention