BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24691627 · Received March 25, 2026

    Report

    Report Number
    2015691-2026-13522
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 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 DEVICES WERE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNITS, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. 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 USE THE SWAN GANZ CATHETER BLUE (CVP) PORT COMPLETELY BROKE IN HALF ON MULTIPLE OCCASIONS. IT WAS UNKNOWN HOW MANY TIMES THIS OCCURRED IN TOTAL. THERE WAS NO PATIENT INJURY. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748435 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES DR 831F75 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown