BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24593934 · Received March 13, 2026

    Report

    Report Number
    2015691-2026-13195
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Report Date
    May 15, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH (B)(4) WAS RECEIVED. ADDITIONAL FDA PRODUCT CODE: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL PREMARKET SUBMISSION: K231248. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND TO SECURE THE RETURN OF THE DEVICE. HOWEVER THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK 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. IN ADDITION, A DEVICE HISTORY RECORD CANNOT BE COMPLETED WITHOUT A LOT NUMBER. IF THE DEVICE IS RETURNED AND/OR ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 THAT THE BLUE, DISTAL PORT OF A SWAN GANZ CATHETER HAD BLOOD LEAKAGE. UPON INSPECTION, THE BLUE LUMEN WAS DETACHED FROM THE HUB OF THE WHITE LUER LOCK ON TOP OF THE CARDIAC OUTPUT SYRINGE. ISSUE WAS A PRODUCT PROBLEM BUT IT WAS NOTED THAT OTHER SERIOUS OR IMPORTANT MEDICAL EVENT OCCURRED. PER THE MEDWATCH REPORT FROM THE CUSTOMER, SECTION B2 WAS CHECKED AS "OTHER SERIOUS AND IMPORTANT MEDICAL EVENT OCCURRED DURING EVENT," BUT THERE IS NO INDICATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125896 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown