BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 24383922 · Received February 18, 2026

    Report

    Report Number
    2015691-2026-11213
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103218282
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AS PART OF THE MANUFACTURING PROCESS, 100% OF THE UNITS GO THROUGH A BALLOON INSPECTION, BALLOON DEFLATION TIME TEST, QUALITY VISUAL INSPECTION, LEAK AND FLOW TEST, AND VISUAL INSPECTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: DQO, DQE, KRA, DQK, DRS, DSB, DXN, QAQ. ADDITIONAL FDA PREMARKET SUBMISSION: K231248. MEDWATCH (B)(4) WAS RECEIVED. DEVICE IS NOT AVAILABLE FOR RETURN. 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. HOWEVER, AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE REPORTED LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING ONCE THE ENGINEERING EVALUATION IS COMPLETE. 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, DURING USE, A SWAN GANZ CATHETER HAD AIR IN THE LINE AND LEAKED AT THE CONNECTION BETWEEN THE TUBING AND WHITE HUB. CATHETER WAS PULLED ONCE THE BEDSIDE RN NOTIFIED STAFF. THE CATHETER WAS SUCCESSFULLY REPLACED AND PATIENT IS CURRENTLY AWAITING CARDIAC TRANSPLANT. THERE WAS NO INJURY TO PATIENT AND NO OTHER SERIOUS MEDICAL EVENT OCCURRED DURING EVENT. IT WAS NOTED THAT THE CATHETER WAS PLACED EARLY BECAUSE THE PATIENT IS A TRANSPLANT PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444552 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 831F75P 66591113 00690103218282

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male