BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH CONTOUR¿ STEERABLE SHEATH

    MDR report key: 24671036 · Received March 23, 2026

    Report

    Report Number
    3002648230-2026-00291
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 23, 2026
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K232321
    Adverse Event
    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: PSCC100 PRODUCT TYPE: CATHETER; PRODUCT ID: 900310 PRODUCT TYPE: TRANSSEPTAL PUNCTURE DEVICE. 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 POST-OPERATIVELY TO A COMPLETED CARDIAC ABLATION PROCEDURE, ACCUMULATION OF PERICARDIAL FLUID WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY, AND A DECREASE IN BLOOD PRESSURE AND CARDIAC TAMPONADE WERE OBSERVED, SO DRAINAGE WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723620 FLEXCATH CONTOUR¿ STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 10FCC13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L SEE H11...