BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS

    MDR report key: 18611090 · Received January 30, 2024

    Report

    Report Number
    2015691-2024-00671
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Report Date
    February 22, 2024
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103000504
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION 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

    OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL 141F7 SWAN-GANZ CATHETER. THE CUSTOMER REPORT OF AIR WOULD NOT RELEASE FROM THE BALLOON WAS UNABLE TO BE CONFIRMED. THE BALLOON INFLATED CLEAR, CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED WITHIN 1 SECOND WITHOUT THE SYRINGE ATTACHED. MAXIMUM DEFLATION TIME FROM FULL CAPACITY WITHOUT A SYRINGE ATTACHED IS 4 SECONDS. PER THE IFU INSTRUCTIONS, PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE AND OPENING THE GATE VALVE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON CATHETER. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT AND NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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 BALLOON OF A 141F7 SWAN GANZ CATHETER WAS NOT ABLE TO DEFLATE. EVENT OCCURRED DURING DEVICE PREP. THERE WAS NO PATIENT INJURY. PRODUCT IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245606 SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR 141F7 65059499 00690103000504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown