BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 22902062 · Received August 27, 2025

    Report

    Report Number
    9612164-2025-04228
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 25, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    UDI-DI
    00763000659080
    PMA / PMN Number
    K232321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10:PRODUCT ID 900310; PRODUCT TYPE: INTEGRATED DILATOR/NEEDLE PRODUCT ID: NON MEDTRONIC PRODUCT PRODUCT TYPE: MAPPING CATHETER 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

    CONTINUATION OF D10: PRODUCT ID: NON-MEDTRONIC UNKNOWN, PRODUCT TYPE: INTRODUCER SHEATH; PRODUCT ID: NON-MEDTRONIC UNKNOWN, PRODUCT TYPE: INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER; PRODUCT ID: NON-MEDTRONIC UNKNOWN, PRODUCT TYPE: HIGH DENSITY MAPPING CATHETER; PRODUCT ID: NON-MEDTRONIC UNKNOWN, PRODUCT TYPE: STEERABLE DIAGNOSTIC CATHETER; PRODUCT ID: NON-MEDTRONIC UNKNOWN, PRODUCT TYPE: GUIDE WIRE. PRODUCT EVENT SUMMARY: THE 10FCC13 SHEATH WITH LOT NUMBER 0012752292 AND PATIENT DATA FILES WERE RETURNED AND ANALYZED. THE DATA FILES WERE IN THE FORM OF ONE IMAGE, WHICH SHOWED A 10FR 13MM FLEXCATH CONTOUR¿ STEERABLE SHEATH WHERE THE SIDE PORT TUBE APPEARED KINKED. LOG FILES CORRESPONDING TO THE CASE EVENT DATE WERE REVIEWED AND NO ERROR CODES WERE IDENTIFIED. VISUAL INSPECTION OF THE SHAFT AND HANDLE REVEALED A SIDE PORT TUBING KINK. 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 RELEVANT SUB-ASSEMBLY INSPECTION AND TESTS WERE PERFORMED. NO ANOMALY WAS DISCOVERED. SCOPE INSPECTION OF THE SHAFT ALSO DID NOT REVEAL ANY ANOMALIES. THE REPORTED CLINICAL ISSUE OF A CLOT OCCURRED DURING THE PROCEDURE AND THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGEMENT OF THE PHYSICIAN. THE SHEATH FAILED THE RETURNED THE PRODUCT INSPECTION DUE TO A SIDE PORT TUBING KINK. 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. 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 THE NDL 900310 FLEXCATH CROSS FCC 10FR AND SHEATH 10FCC13 FLEXCATH CONTOUR 10F, THE PROCEDURE WAS ABORTED AFTER A LARGE "CLOT" WAS VISUALIZED IN THE LEFT ATRIUM ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) FOLLOWING TRANSSEPTAL PUNCTURE AND MAPPING CATHETER INSERTION. ICE WAS INITIALLY USED TO CONFIRM THE ABSENCE OF EFFUSION OR CLOT BEFORE THE TRANSSEPTAL PUNCTURE. AFTER THE EVENT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED TO VERIFY THE LOCATION OF THE "CLOT" OR TISSUE. THE PATIENT WAS ADEQUATELY ANTICOAGULATED THROUGHOUT THE PROCEDURE. INTERVENTIONAL RADIOLOGY SUCTIONED THE MATERIAL FROM THE LEFT ATRIUM USING A SMALLER CATHETER THROUGH THE FLEXCATH CONTOUR SHEATH, AND IT WAS DETERMINED TO BE TISSUE BELIEVED TO HAVE BEEN ATTACHED TO THE SEPTUM OR PUSHED INTO THE LEFT ATRIUM DURING THE TRANSSEPTAL PUNCTURE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT'S HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED AS A PRECAUTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    NOTHING WAS FOUND ON THE CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467713 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC13 0012752292 00763000659080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11...