BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8186173 · Received December 20, 2018

    Report

    Report Number
    3001627457-2018-00041
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    January 26, 2014
    Report Date
    November 29, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPED HEMOPTYSIS AND CARDIAC ARREST DURING CATHETER PLACEMENT FOR A UNILATERAL PE. THE DEVICE WAS PLACED, BUT TREATMENT WAS ABORTED DUE TO CARDIAC ARREST AND HEMOPTYSIS. THE INVESTIGATOR ASSESSED THE HEMOPTYSIS AS SERIOUS AND PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE, EKOS SYSTEM, THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG. THE INVESTIGATOR ASSESSED THE CARDIAC ARREST AS SERIOUS AND PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE AND EKOS SYSTEM. THE CARDIAC ARREST WAS ASSESSED AS NOT RELATED TO THE THROMBOLYTIC DRUG OR ANTICOAGULANT DRUG. THE PATIENT RECOVERED, BUT WAS NOT TREATED IN THE STUDY. THE IFU LISTS CARDIAC ARRHYTHMIAS AS A POTENTIAL COMPLICATION MOST FREQUENTLY OCCURRING DURING PLACEMENT, REMOVAL OR FOLLOWING DISPLACEMENT INTO THE RIGHT VENTRICLE. THE BTG PHYSICIAN ASSESSED THE HEMOPTYSIS PROBABLY RELATED TO THE THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG, POSSIBLY RELATED TO THE INTERVENTIONAL PROCEDURE AND UNLIKELY RELATED TO THE EKOS DEVICE. THE BTG PHYSICIAN IS IN AGREEMENT WITH THE INVESTIGATOR AND ASSESSED THE CARDIAC ARREST AS PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE AND EKOS DEVICE, AND NOT RELATED TO THE THROMBOLYTIC DRUG OR ANTICOAGULANT DRUG. NO DEVICE SERIAL NUMBERS WERE DOCUMENTED IN THE CLINICAL STUDY FILE. NO ADDITIONAL INFORMATION WILL BE AVAILABLE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT WAS TREATED WITH EKOS ON (B)(6) 2014 FOR A UNILATERAL PE. THE DEVICE WAS NOT SUCCESSFULLY USED FOR TREATMENT. THE DEVICE WAS PLACED, BUT TREATMENT WAS ABORTED AFTER 1.5 HOURS DUE TO A CARDIAC ARREST AND HEMOPTYSIS. THE PATIENT DEVELOPED CARDIAC ARREST AND HEMOPTYSIS DURING THE PLACEMENT PROCEDURE ON (B)(6) 2014 AT 01:00. THE PATIENT WAS TREATED WITH CARDIOPULMONARY RESUSCITATION, FLUID AND MEDICAL RESUSCITATION. THE CARDIAC EVENT RESOLVED AT 01:15 ON (B)(6) 2014. THE PATIENT RECEIVED A TRANSFUSION OF RBC (4 UNITS) AND PLASMA (1 UNIT) AND THE HEMOPTYSIS RESOLVED ON (B)(6) 2014 AT 10:00. THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT. ANTICOAGULATION SUMMARY: (B)(6) 2014: ASPIRIN 325MG PO, HEPARIN BOLUS 6660IU IV. (B)(6) 2014: TRANEXAMIC ACID 938 MG IV (TO TREAT THE HEMOPTYSIS). (B)(6) 2014: HEPARIN BOLUS 5000IU SC. (B)(6) 2014: WARFARIN 5MG PO. (B)(6) FEB 2014: WARFARIN 5MG PO. (B)(6) FEB 2014: WARFARIN 6MG PO. (B)(6) FEB 2014: ASPIRIN 325MG PO. (B)(6) FEB 2014: WARFARIN 7MG PO. (B)(6) 2014: ASPIRIN 81MG PO. (B)(6) 2014: WARFARIN 6MG PO. (B)(6) 2014: WARFARIN 5MG PO. (B)(6) 2014: WARFARIN 10MG PO. THIS PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY KNOCOUT PE (SUBJECT (B)(6)). THE INVESTIGATOR ASSESSED THE HEMOPTYSIS AS SERIOUS AND PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE, EKOS SYSTEM, THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG. THE INVESTIGATOR ASSESSED THE CARDIAC ARREST AS SERIOUS AND PROBABLY RELATED TO THE INTERVENTIONAL PROCEDURE AND EKOS SYSTEM. THE CARDIAC ARREST WAS ASSESSED AS NOT RELATED TO THE THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026461 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L