BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 22189580 · Received June 11, 2025

    Report

    Report Number
    9612164-2025-02873
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 11, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    PMA / PMN Number
    K232321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 900310 (106877); PRODUCT TYPE: 3288-ACQ NEEDLE; IMPLANT DATE N/A; EXPLANT DATE N/A . MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ABLATION PROCEDURE INVOLVING TRANSEPTAL PUNCTURE, THE 900310 FLEXCATH CROSS WAS USED WHEN YELLOW FLUID WAS ASPIRATED IMMEDIATELY AFTER THE TRANSEPTAL PUNCTURE, AND THE PHYSICIAN SUSPECTED A SMALL TAMPONADE HAD OCCURRED AT THAT TIME. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PHYSICIAN BELIEVED THE EVENT WAS ASSOCIATED WITH THE TRANSEPTAL PUNCTURE STEP. THE PATIENT REMAINED STABLE, AND THE CASE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102583 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC20 0012521949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening