BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 23213530 · Received October 3, 2025

    Report

    Report Number
    9612164-2025-04900
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    PMA / PMN Number
    K232321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PSG100 (SERIAL: UNKNOWN); PRODUCT TYPE: 3294-GENERATOR PRODUCT ID 900310 (106647); PRODUCT TYPE: 3288-ACQ NEEDLE PRODUCT ID 900310 (106379); PRODUCT TYPE: 3288-ACQ NEEDLE 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.

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE 10FCC13 SHEATH WITH LOT NUMBER 0012897272 WAS RETURNED AND ANALYZED. EXTERNAL VISUAL INSPECTION BEFORE FUNCTIONAL TESTING AND DISSECTION WAS PERFORMED ON THE SHAFT AND HANDLE. NO ANOMALIES WERE IDENTIFIED; THE HANDLE, SHAFT, AND SIDE PORT WERE INTACT WITH NO APPARENT ISSUES. FUNCTIONAL TESTING WAS PERFORMED; NO ANOMALY WAS DISCOVERED. THE STEERING MECHANISM AND DEFLECTION TESTS WERE COMPLETED SUCCESSFULLY. PRIMARY DEFLECTION AT 90° AND 180°, AS WELL AS SECONDARY DEFLECTION AT 90°, WERE ACHIEVED WITHOUT ANY ISSUES. THE MECHANISM OPERATED SMOOTHLY, WITH NO FRICTION, RESISTANCE, OR UNUSUAL NOISE. THE PERFORMANCE TEST WITH A LEAK TESTER WAS PERFORMED. THE PRESSURE AND ASPIRATION TESTS WERE IN THE ACCEPTABLE RANGE. THE SHAFT, SIDE TUBE, AND VALVE WERE ALL LEAK-TIGHT WITH NO APPARENT ISSUES. THE RELEVANT SUB-ASSEMBLY INSPECTION AND TESTS WERE PERFORMED; NO ANOMALIES WERE DISCOVERED. IN CONCLUSION, THE REPORTED "AIR INGRESS" ISSUE WAS NOT OBSERVED/REPRODUCED WITH THE RETURNED SHEATH. THE SHEATH PASSED THE RETURNED PRODUCT INSPECTION PER SPECIFICATION. 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 PULSED FIELD ABLATION PROCEDURE, WHEN THE SHEATH WAS ADVANCED TO THE SUPERIOR VENA CAVA (SVC) THE GUIDEWIRE WAS PULLED TO WIPE AWAY THROMBUS. WHEN THE RETROGRADE BLOOD FLOW WAS DRAWN FROM THE INTEGRATED DILATOR/NEEDLE AIR CONTINUED TO BE ASPIRATED. THE INTEGRATED DILATOR/NEEDLE WAS REPLACED. THE SAME PHENOMENON OCCURRED. THE CASE WAS SWITCHED TO ANOTHER MANUFACTURER'S PRODUCT AND THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT WHEN THE INTEGRATED DILATOR/NEEDLE WAS REPLACED THE AIR INGRESS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587538 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC13 0012897272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...