BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ VIP

    MDR report key: 23416458 · Received October 29, 2025

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    Report

    Report Number
    2015691-2025-08919
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Report Date
    November 12, 2025
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DYG
    UDI-DI
    00690103003031
    PMA / PMN Number
    K160084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. ONE MODEL 831F75 CATHETER WITH MONOJECT LIMITED VOLUME SYRINGE AND NON-EDWARDS CONTAMINATION SHIELD WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF LEAKAGE WAS CONFIRMED. VISUAL EXAMINATION FOUND THAT PROXIMAL INJECTATE EXTENSION TUBE WAS PARTIALLY BROKEN AT THE LUMEN HUB. CROSS SURFACE OF THE BROKEN EXTENSION TUBE APPEARED TO BE UNEVEN AND ROUGH. DISTAL LUMEN WAS OCCLUDED WITH BLOOD. INFUSION LUMEN WAS PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR MORE THAN 5 MINUTES WITHOUT LEAKAGE. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM CATHETER. 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

    AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE EVIDENCE, IT WAS IDENTIFIED THAT THE ASSEMBLY OF THE COMPONENTS WHERE THE LEAKAGE OCCURS IS NOT MANUFACTURED INTERNALLY IN THE DOMINICAN REPUBLIC BD APM MANUFACTURING PROCESS. THE AFFECTED ASSEMBLY IS MANUFACTURED BY EDWARDS PUERTO RICO. CONSEQUENTLY, THIS IS A SUPPLIER RELATED CONDITION, AND THE CORRESPONDING SUPPLIER NOTIFICATION WAS SENT. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS UNDERGO A LEAK AND FLOW TEST AND A VISUAL INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE SWAN-GANZ CATHETER, THERE WAS A PINHOLE SIZED LEAK BELOW ONE OF THE PORTS. THE CATHETER WAS EXCHANGED FOR A NEW ONE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214246 SWAN-GANZ VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES DR 831F75 NI 00690103003031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown