BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8184645 · Received December 20, 2018

    Report

    Report Number
    3001627457-2018-00040
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    January 13, 2017
    Report Date
    November 29, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT RECEIVED EKOS THERAPY ON (B)(6) 2017 AND DEVELOPED A RETROPERITONEAL HEMATOMA DURING TREATMENT. THE PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY - (B)(6) (SUBJECT (B)(6)). THE PRINCIPLE INVESTIGATOR ASSESSED THE RETROPERITONEAL HEMATOMA AS SERIOUS AND DEFINITELY RELATED TO THE INTERVENTIONAL PROCEDURE AND PROBABLY RELATED TO THE EKOS SYSTEM, THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG. THE BTG PHYSICIAN IS IN AGREEMENT WITH THE PRINCIPLE INVESTIGATOR'S ASSESSMENT THAT THE EVENT IS RELATED TO THE INTERVENTIONAL PROCEDURE. THE BTG PHYSICIAN ASSESSED THE RETROPERITONEAL HEMATOMA AS RELATED TO THE INTERVENTIONAL PROCEDURE, THROMBOLYTIC DRUG AND/OR ANTICOAGULANT DRUG, AND POSSIBLY RELATED TO THE EKOS SYSTEM. THIS EVENT IS BEING REPORTED DUE TO THE RELATIONSHIP ASSESSMENT MADE BY THE PRINCIPLE INVESTIGATOR AS DEFINITELY RELATED TO THE INTERVENTIONAL PROCEDURE AND PROBABLY RELATED TO THE EKOS SYSTEM. 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) 2017 FOR A BILATERAL PE. EKOS TREATMENT WAS TERMINATED ON (B)(6) 2017 (APPROXIMATELY 8 HOURS OF "THREATMENT"). THE PATIENT "RECIEVED" A TOTAL DOSE OF 10 MG R-TPA (5 MG R-TPA THROUGH CATHETER PLACED IN RIGHT PULMONARY ARTERY AND 5 MG R-TPA THROUGH CATHETER PLACED IN LEFT PULMONARY ARTERY). THE PATIENT DEVELOPED A RETROPERITONEAL HEMATOMA DURING THE STUDY TREATMENT AND DEVELOPED HYPOTENSION A FEW HOURS AFTER EKOS PROCEDURE W/MAP 60-64 AND HB DROPPED TO 8.9 FROM 13.2 PRE-PROCEDURE. THE PATIENT RECEIVED NON-SURGICAL DRUG TREATMENT (SALINE BOLUS 2000ML IV) AND A TRANSFUSION OF RBC (2 UNITS/350 ML). THE RETROPERITONEAL HEMATOMA RESOLVED ON (B)(6) 2017. THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT. ANTICOAGULATION SUMMARY: ON (B)(6) 2017: ASPIRIN 324MG PO, HEPARIN BOLUS 5000IU IV, HEPARIN INFUSION 1500UNITS/HR IV. ON (B)(6) 2017: ASPIRIN 81MG PO, HEPARIN INFUSION 1200UNITS/HR IV. ON (B)(6) 2017: ENOXAPARIN 90MG SC, HEPARIN INFUSION 1300UNITS/HR IV. ON (B)(6) 2017: HEPARIN INFUSION 1200UNITS/HR IV. ON (B)(6) 2017: HEPARIN INFUSION 1300UNITS/HR IV. ON (B)(6) 2017: APIXABAN 10MG PO. THIS PATIENT WAS ENROLLED IN A RETROSPECTIVE STUDY (B)(6) (SUBJECT (B)(6)). THE INVESTIGATOR ASSESSED THE EVENT AS SERIOUS AND DEFINITELY RELATED TO THE INTERVENTIONAL PROCEDURE AND PROBABLY RELATED TO THE EKOS SYSTEM, THROMBOLYTIC DRUG AND ANTICOAGULANT DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024458 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization