BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH

    MDR report key: 6679424 · Received June 29, 2017

    Report

    Report Number
    2015691-2017-01906
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WITH ATTACHED MONOJECT 1.5 CC LIMITED VOLUME SYRINGE AT GATE VALVE AND TWO NON-EDWARDS THREE-WAY STOPCOCKS ATTACHED AT THE PROXIMAL INJECTATE HUB AND P.A. DISTAL HUB, RESPECTIVELY WERE RETURNED FOR EVALUATION. THE THERMISTOR CONNECTOR EXTENSION TUBE WAS TIED. THE INTRODUCER AND CONTAMINATION SHIELD WERE ALSO ATTACHED TO THE CATHETER BODY BETWEEN 43.5 CM AND 77 CM AREA PROXIMAL FROM THE CATHETER TIP. THE INTRODUCER AND THE CONTAMINATION SHIELD WERE REMOVED FOR FURTHER EVALUATION. CLOTTED BLOOD WAS OBSERVED FROM THE THERMISTOR CONNECTOR AND CONNECTOR HOUSING. AS RECEIVED, CATHETER WAS CUT OFF AT 41.9 CM AND THE PART FROM THE TIP OF THE CATHETER TO 41.9 CM WAS NOT RETURNED. CROSS SURFACE OF THE CATHETER APPEARED TO BE SMOOTH. ALL THROUGH LUMENS LEAKED ONLY FROM THE CUT SECTION. THE THERMISTOR / ELECTRODE EXTENSION TUBE WAS CUT IN HALF JUST DISTAL OF THE "Y" FITTING FOR LEAK TESTING. LEAKAGE WAS OBSERVED ONLY FROM THE CUT SECTION WHEN AIR WAS INJECTED INTO THE THERMISTOR / ELECTRODE LUMEN. OPTICAL MODULE CONNECTOR WAS OPENED, AND NO VISIBLE, ABNORMALITY OR BLOOD WAS OBSERVED. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. CUSTOMER REPORT OF ¿LEAKAGE WAS OBSERVED FROM THE THERMISTOR CONNECTOR ¿ WAS CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS IS WELL DESCRIBED IN THE LITERATURE. THE PRODUCT INSTRUCTIONS FOR USE (IFU) INFORM THE CLINICIAN THAT THE INCIDENCE OF COMPLICATIONS INCREASES SIGNIFICANTLY WITH INDWELLING PERIODS GREATER THAN 72 HOURS. 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 PART OF THIS MONTHLY REVIEW. (B)(4).

    Description of Event or Problem · 1

    INITIALLY, IT WAS REPORTED THAT BLOOD LEAKAGE WAS OBSERVED FROM THE THERMISTOR CONNECTOR ON THE FIRST DAY OF USE. UPON ATTEMPTING TO REMOVE THE CATHETER ON THE 14TH DAY OF USE, IT WAS BELIEVED THAT THE CATHETER WAS SEWN TO THE AREA AROUND THE SVC AND UNABLE TO BE REMOVED. THE PATIENT¿S CHEST HAD TO BE REOPENED. AN ADDITIONAL SUTURE ON THE SUPERIOR VENA CAVA WAS UNTIED BUT THE CATHETER WAS UNABLE TO BE REMOVED. BASED ON THE PATIENT¿S CONDITION, CARDIOPULMONARY BYPASS WAS RULED OUT AS AN OPTION TO REMOVE THE CATHETER. A CUT DOWN WAS PERFORMED NEAR THE INTERNAL JUGULAR VEIN AND THE CATHETER WAS CUT. THE INTRODUCER WAS REMOVED AT THIS TIME. THE INCISION WAS CLOSED WITH A PORTION OF THE CATHETER REMAINING IN THE PATIENT. SURGERY TO REMOVE THE SECTION OF THE CATHETER REMAINING INSIDE THE PATIENT HAS NOT YET BEEN SCHEDULED AND THE PATIENT CONDITION IS UNKNOWN AT THIS TIME. COMPLETE PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457002 SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT DYG EDWARDS LIFESCIENCES, PR TOE135F75 60810986

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention