BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIASAT

    MDR report key: 23770701 · Received December 10, 2025

    Report

    Report Number
    2015691-2025-09929
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Report Date
    February 18, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DRE
    UDI-DI
    00690103197570
    PMA / PMN Number
    K053609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED FOR PRODUCT EVALUATION. THE REPORTED EVENT OF LEAKAGE ISSUE WAS CONFIRMED. LEAKAGE WAS DETECTED FROM BACKFORM TO CATHETER BODY JUNCTION WHEN DISTAL LUMEN WAS PRESSURIZED. ALL OTHER THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO OTHER VISIBLE INCONSISTENCY WAS OBSERVED FROM THE RETURNED CATHETER. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A LEAK TEST.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQE, DXG. ADDITIONAL PREMARKET SUBMISSION: K110167. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. HOWEVER, A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A SERIAL NUMBER 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, AFTER CATHETER PLACEMENT DURING USE IN PATIENT WHEN BLOOD BACKFLOW WAS CHECKED, A PEDIASAT OXIMETRY CATHETER ASPIRATED AIR. IT IS UNCLEAR WHICH LUMEN (DISTAL, MEDIAL, PROXIMAL) ASPIRATED AIR. NO MEDICATION LEAKAGE OCCURRED. AFTER THE CATHETER REMOVAL, THE CUSTOMER PERFORMED A TEST IN THE WATER AND FOUND A HOLE ON THE PATIENT (DISTAL) SIDE OF BACKFORM, AND LEAKAGE WAS OBSERVED FROM THE SAME LOCATION. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043067 PEDIASAT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE EDWARDS LIFESCIENCES PR XT3515SJ 00690103197570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown