BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 24264181 · Received February 4, 2026

    Report

    Report Number
    2015691-2026-10817
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 12, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    UDI-DI
    00690103043501
    PMA / PMN Number
    K240078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: KRA ADDITIONAL PREMARKET SUBMISSION: K892410. A PRODUCT EVALUATION CANNOT BE COMPLETED AS THE DEVICE WAS DISCARDED. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. HOWEVER, AN INVESTIGATION WILL BE INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. THE INSTRUCTIONS FOR USE (IFU) INCLUDES THE FOLLOWING WARNING: USE OF A HIGHLY VISCOUS OR PARTICULATE CONTRAST MEDIUM IS NOT RECOMMENDED FOR BALLOON INFLATION BECAUSE THE INFLATION LUMEN MAY BECOME OCCLUDED. THE IFU ALSO INSTRUCTS THE CLINICIAN TO INSPECT THE CATHETER WITH THE BALLOON INFLATED DURING PURGING. A BALLOON THAT DOES NOT INFLATE, LEAKS, OR INFLATES IN A GROSSLY ASYMMETRIC (ECCENTRIC) MANNER SHOULD NOT BE USED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    AS REPORTED, DURING DEVICE PREP, THE BALLOON OF A FOGARTY THRU-LUMEN CATHETER COULD NOT BE DEFLATED. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285754 FOGARTY CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES PR 12TLW803F 65906518 00690103043501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown