BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24676676 · Received March 24, 2026

    Report

    Report Number
    2015691-2026-13473
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    January 30, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED IN MEDWATCH FORM 5183642 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 FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351893 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P NI 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1