BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 20894888 · Received December 10, 2024

    Report

    Report Number
    9612164-2024-05903
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    September 9, 2024
    Report Date
    December 10, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DRA
    UDI-DI
    00763000659080
    PMA / PMN Number
    K232321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION FROM D10: PRODUCT ID: 900310 PRODUCT TYPE: INTEGRATED NEEDLE/DILATOR; PRODUCT ID: 900310 PRODUCT TYPE: INTEGRATED NEEDL E/DILATOR; PRODUCT ID: 10FCC13 PRODUCT TYPE: SHEATH PRODUCT EVENT SUMMARY: THE 10FCC13 SHEATH WITH LOT NUMBER 0012351796 WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE HANDLE TUBE AREA WAS PERFORMED. THE INSPECTION IDENTIFIED A KINK AT THE SIDE PORT TUBE. NO ADDITIONAL VISUAL ANOMALIES WERE DETECTED. THE STEERING MECHANISM AND DEFLECTION TEST WERE PERFORMED. NO ANOMALY WAS DISCOVERED. THE FUNCTIONAL TESTING WAS PERFORMED. NO ANOMALY WAS DISCOVERED. THE NATIVE DILATOR WAS INSERTED INTO THE SHEATH AND RETRACTED SEVERAL TIMES, WITHOUT ANY FRICTION. THE NATIVE DILATOR WAS SNAP-LOCKED TO THE SHEATH AND WAS TIGHT. THE PERFORMANCE TEST WITH USON LEAK TESTER WAS PERFORMED. THE PRESSURE TEST WITH 45 POUNDS PER SQUARE INCH GAUGE (PSIG) SHOWED THE PRESSURE DECAY IN THE DEVICE WAS 0.133 PSIG AND IN AN ACCEPTABLE RANGE. THE VACUUM TEST WITH A NEGATIVE PRESSURE OF 8.5 PSIG SHOWED THE PRESSURE DECAY IN THE DEVICE WAS 0.0083 PSIG AND IN AN ACCEPTABLE RANGE. IN CONCLUSION, THE SHEATH FAILED THE RETURNED 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. 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 CRYO ABLATION PROCEDURE, THE HUB CONNECTION OF THE SHEATH AND THE INTEGRATED NEEDLE/DILATOR WAS NOT STRONG ENOUGH. THE CONNECTION SEPARATED MULTIPLE TIMES. THE SHEATH AND THE NEEDLE/DILATOR WERE REPLACED WITHOUT RESOLUTION. EVENTUALLY, THE WIRE WAS KEPT IN THE LEFT ATRIUM AND REMOVED THE NEEDLE/DILATOR, THEN INTRODUCED THE NATIVE DILATOR OVER THE WIRE AND CROSSED WITH EASE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501998 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC13 0012351796 00763000659080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown