BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8057738 · Received November 9, 2018

    Report

    Report Number
    3001627457-2018-00032
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    April 19, 2016
    Report Date
    November 27, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP #1 NARRATIVE: THE ADVERSE EVENT RELATIONSHIP HAS BEEN UPDATED. THE PRINCIPLE INVESTIGATOR ASSESSED THE RELATIONSHIP OF THE ICH AS NOT RELATED TO THE INTERVENTIONAL PROCEDURE, STUDY DEVICE OR THROMBOLYTIC DRUG. THE ICH WAS ASSESSED AS DEFINITELY RELATED TO THE ANTICOAGULANT DRUG.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP #1 REPORT SUBMITTED TO UPDATE THE RELATIONSHIP ASSESSMENT MADE BY THE PRINCIPLE INVESTIGATOR. (REFERENCE TO H.10). REFER TO THE INITIAL MDR FOR THE EVENT DESCRIPTION.

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED EKOS THERAPY IN (B)(6) 2015. NEARLY ONE YEAR FOLLOWING THE SUCCESSFUL EKOS TREATMENT, THIS PATIENT DEVELOPED AN ICH IN (B)(6) 2016. THE PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY - (B)(6) (SUBJECT (B)(6)). THE PRINCIPLE INVESTIGATOR ASSESSED THE RELATIONSHIP OF THE ICH TO THE STUDY DEVICE AS UNKNOWN, THE RELATIONSHIP TO THE THROMBOLYTIC AS UNKNOWN AND THE RELATIONSHIP TO ANTICOAGULATION AS UNKNOWN. THE BTG PHYSICIAN HAS ASSESSED THIS EVENT AS UNRELATED TO THE STUDY DEVICE. A QUERY WAS SENT TO THE STUDY SITE TO CONFIRM THE RELATIONSHIP ASSESSMENT, BUT TO DATE NO UPDATE HAS BEEN RECEIVED. THIS EVENT IS BEING REPORTED DUE TO THE CURRENT RELATIONSHIP ASSESSMENT MADE BY THE PRINCIPLE INVESTIGATOR.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WAS TREATED WITH EKOS ON (B)(6) 2015 FOR A BILATERAL PE. EKOS TREATMENT RAN FOR 17 HOURS WITH A TOTAL DOSE OF 34 MG R-TPA (17 MG R-TPA THROUGH CATHETER PLACED IN RIGHT PULMONARY ARTERY AND 17 MG R-TPA THROUGH CATHETER PLACED IN LEFT PULMONARY ARTERY) WITHOUT ISSUE. ON (B)(6) 2016, NEARLY ONE YEAR AFTER EKOS TREATMENT, CT AND LABORATORY TEST CONFIRMED AN INTRACRANIAL HEMORRHAGE. A NON-SURGICAL DRUG TREATMENT WAS PROVIDED TO THE PATIENT AND THE ICH RESOLVED ON 02 (B)(6) 2016. THIS EVENT WAS NOT REPORTED TO BE ASSOCIATED WITH THE EKOS DEVICE/TREATMENT BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT. THIS PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY (B)(6) (SUBJECT (B)(6)). THE ICH WAS CLASSIFIED AS A CLINICAL STUDY SAE BY THE PRINCIPLE INVESTIGATOR ON 12 OCT 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896346 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention