BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN GANZ UNKNOWN

    MDR report key: 23619256 · Received November 21, 2025

    Report

    Report Number
    2015691-2025-09472
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Report Date
    November 21, 2025
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DQO- CATHETER, INTRAVASCULAR, DIAGNOSTIC. DQE- CATHETER, OXIMETER, FIBEROPTIC. KRA- CATHETER, CONTINUOUS FLUSH. DQK- COMPUTER, DIAGNOSTIC, PROGRAMMABLE. DRS- TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR. DSB- PLETHYSMOGRAPH, IMPEDANCE. DXN- SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. QAQ- ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. WITHOUT 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. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AS A PRECAUTION, THE INSTRUCTIONS FOR USE CONTAIN INSTRUCTIONS ON HOW TO PROPERLY INSERT THE CATHETER INTO THE HEART.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PLACEMENT OF THE SWAN-GANZ CATHETER, WHEN TRYING TO FLOAT IT, THE CATHETER WOULD GET CAUGHT AROUND THE PATIENT'S AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD). TO REPLACE THE CATHETER THE PATIENT REQUIRED AN EMERGENT TRIP TO THE CATH LAB. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117579 SWAN GANZ UNKNOWN CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN NI 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other