BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 21683232 · Received March 24, 2025

    Report

    Report Number
    2015691-2025-02210
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 25, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    MJN
    UDI-DI
    00690103043747
    PMA / PMN Number
    K093911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS UNDERGO A BALLOON INSPECTION. LATEX DETERIORATION IS "A CONDITION USUALLY CAUSED BY AGE, EXCESSIVE EXPOSURE TO LIGHT, ATMOSPHERE, OR OZONE. APPEARS ON THE BALLOON SURFACE AS A MAZE OF FINE CRACKS OR CRAZING. THE CONDITION MAY OCCUR IN A SMALL AREA OR COVER THE ENTIRE BALLOON". BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. COMPLAINTS INCIDENCE WILL CONTINUE TO BE MONITORED, AND APPLICABLE ACTIONS WILL BE TAKEN AS REQUIRED.

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED 62080814F CATHETER. THE REPORTED EVENT OF BALLOON INFLATION ISSUE WAS CONFIRMED. BALLOON DID NOT INFLATE DUE TO LEAKAGE FROM THE DISTAL AREA OF THE BALLOON. CLOSER EXAMINATION FOUND THAT THE BALLOON WAS DETERIORATED AND MANY TEARS WERE OBSERVED AT THE DISTAL AREA OF THE BALLOON. THE EDGES OF TEAR APPEARED TO BE MATCHED UP. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM BOTH WINDINGS AND CATHETER BODY. THE ENGINEERING EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD CANNOT BE REVIEWED. 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. ADDITIONAL FDA PREMARKET SUBMISSION IS K152762.

    Description of Event or Problem · 0

    AS REPORTED, DURING USE IN PATIENT, THE BALLOON OF THIS FOGARTY CATHETER DID NOT INFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543161 FOGARTY CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EDWARDS LIFESCIENCES PR 62080814F 00690103043747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown