BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CCOMBO V

    MDR report key: 18378979 · Received December 21, 2023

    Report

    Report Number
    2015691-2023-18700
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 3, 2023
    Report Date
    July 18, 2024
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103146554
    PMA / PMN Number
    K040287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY THE FOLLOWING ARE ADDITIONAL PRODUCT CODES FOR THIS DEVICE: KRA CATHETER, CONTINUOUS FLUSH DQE CATHETER, OXIMETER, FIBEROPTIC DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC THE FOLLOWING IS CORRECTED DATA, AS THE ORIGINAL IDENTIFICATION INFORMATION SENT DID NOT MATCH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID): BRAND NAME: SWAN-GANZ CCOMBO V D2A: COMMON DEVICE NAME: CATHETER, FLOW DIRECTED D2B: DYG

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE HOSPITAL IS CONFIDENTIAL AND THE PRODUCT AVAILABILITY WAS NOT SHARED. 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. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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 WHEN ATTEMPTING TO REMOVE THE CATHETER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. CUSTOMER WAS ABLE TO REMOVE THE CATHETER WITH THE BALLOON STILL INFLATED. THERE WAS NO PATIENT INJURY, CUSTOMER BELIEVES THE CATHETERS WERE FROM EITHER LOT #64927825 OR LOT #64921991.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200713 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 777F8 64921991 OR 64927825 00690103146554
    288243 SWAN-GANZ CCOMBO V CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 777F8 64921991 OR 64927825 00690103146554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown