BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 21851663 · Received April 16, 2025

    Report

    Report Number
    9612164-2025-01950
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    November 21, 2024
    Report Date
    April 16, 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

    PRODUCT EVENT SUMMARY: IMAGES AND THE 10FCC13 SHEATH WITH LOT NUMBER 0012373155 WAS RETURNED AND ANALYZED. THE TWO IMAGES SHOWED THE DILATOR HALF INSERTED AND A LOOP CATHETER IN THE FIELD. THE PHYSICAL PRODUCT WAS VISUALLY INSPECTED. THE INSPECTION IDENTIFIED A KINK AT THE SIDE PORT TUBE. THE TIP OF THE SHEATH WAS INTACT WITH NO ANOMALY. THE STEERING MECHANISM AND DEFLECTION TEST WERE PERFORMED. THE HANDLE SHELLS OPENED DURING THE MAIN DEFLECTION,180 DEGREES, AND REJOINED ONCE THE DEFLECTION RETURNED TO THE NEUTRAL POSITION. THE LAB TEST DILATOR WAS INSERTED INTO THE SHEATH AND ENCOUNTERED RESISTANCE AT 25.5 INCHES FROM THE TIP. AFTER BEING FORCED FORWARD, A SECOND RESTRICTION WAS ENCOUNTERED AT 7.5 INCHES FROM THE TIP, AT WHICH POINT THE MOVEMENT STOPPED. X-RAYS DID NOT REVEAL ANY PRODUCT MALFUNCTION. THE PERFORMANCE TEST WITH THE SENTINEL BLACKBELT LEAK TESTER WAS PERFORMED AND WERE IN ACCEPTABLE RANGES. IN C ONCLUSION, THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE KINKED SIDE PORT TUBING. 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 PRIOR TO A PULSED FIELD ABLATION PROCEDURE, GUIDEWIRE DID NOT ADVANCE INTO THE LOOP CATHETER ONCE IT ENTERED A CERTAIN LENGTH AND DID NOT EXTEND PAST THE TIP. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. ADDITIONALLY, THE DILATOR COULD NOT BE INSERTED INTO THE SHEATH. THE SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117056 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC IRELAND 10FCC13 0012373155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown