BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24676678 · Received March 24, 2026

    Report

    Report Number
    2015691-2026-13474
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 8, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. HOWEVER, A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE ENGINEERING EVALUATION IS COMPLETED. 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 Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS UNDERGO A LEAK AND FLOW TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED IN MEDWATCH FORM 5183640 THAT DURING USE OF THE SWAN-GANZ CATHETER, DURING A CATHETER REPLACEMENT PROCEDURE, THE STAFF NOTICED BLOOD LEAKING FROM ONE OF THE PORTS AND IDENTIFIED A CRACK IN THE TUBING. THE CATHETER WAS CLAMPED AND REMOVED. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REPLACE THE HEART MONITORING CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE AS NO CONTACT INFORMATION WAS PROVIDED IN THE MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351894 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P NI 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown