Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Lot Number 8035891211
Device Problems Connection Problem (2900); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  Injury  
Event Description
It was reported that the patient had to return to the operating room for device exchange.Two ekos endovascular devices, 106x12cm were selected for use in a case of bilateral pulmonary embolism.Both ekos devices were placed in the operating room, and the patient was transferred to the intensive care unit (icu) to receive ekos therapy.When the ekos devices were connected to the control unit, neither ekos device worked.As a result, the patient was returned to the operating room and both ekos devices were exchanged.Due to the delay in receiving ekos ultrasound therapy, the patient condition worsened.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
 
Manufacturer Narrative
Updated fields: b5 - describe event or problem.H6 - device codes, evaluation method codes, evaluation results codes, evaluation conclusion codes.
 
Event Description
It was reported that the patient had to return to the operating room for device exchange.Two ekos endovascular devices, 106x12cm were selected for use in a case of bilateral pulmonary embolism.Both ekos devices were placed in the operating room, and the patient was transferred to the intensive care unit (icu) to receive ekos therapy.When the ekos devices were connected to the control unit, neither ekos device worked.As a result, the patient was returned to the operating room and both ekos devices were exchanged.Due to the delay in receiving ekos ultrasound therapy, the patient condition worsened.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.It was further reported that an error e311 appeared on the control unit when the ekos devices were connected.
 
Manufacturer Narrative
Device eval by manufacturer: an ekos endovascular device, 106x12 cm (lot# 8035891211) was returned to arden hill for analysis.Visual inspection the inner catheter showed no abnormalities.Measuring lengths of the inner catheter were within spec at 107.5 cm from the distal end of the strain relief.Functional test was completed by connecting the device to an ekos console and running the infusion process for an hour.No alarms displayed.The report of an error from the field was not able to be confirmed.
 
Event Description
It was reported that the patient had to return to the operating room for device exchange.Two ekos endovascular devices, 106x12cm were selected for use in a case of bilateral pulmonary embolism.Both ekos devices were placed in the operating room, and the patient was transferred to the intensive care unit (icu) to receive ekos therapy.When the ekos devices were connected to the control unit, neither ekos device worked.As a result, the patient was returned to the operating room and both ekos devices were exchanged.Due to the delay in receiving ekos ultrasound therapy, the patient condition worsened.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.It was further reported that an error e311 appeared on the control unit when the ekos devices were connected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EKOS ENDOVASCULAR DEVICE, 106X12CM
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19027434
MDR Text Key339183867
Report Number2124215-2024-19139
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number8035891211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EKOS ENDOVASCULAR DEVICE, 106X12CM; EKOS ENDOVASCULAR DEVICE, 106X12CM; EKOS ENDOVASCULAR DEVICE, 106X12CM
Patient Outcome(s) Required Intervention;
-
-