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
Model Number 500-55112
Device Problems Difficult to Flush (1251); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2023
Event Type  malfunction  
Event Description
It was reported that a drug occlusion occurred.A 106x12cm ekosonic endovascular device was selected for use.Two ekosonic catheters were placed without problems.However, after transferring the patient to the intensive care unit, there was a lot of reflux.It was not possible to flush the drug line of the catheter.The drug lumen was occluded.The catheter was pulled but not replaced.The other ekosonic catheter continued without issue until the end of the procedure.No patient complications were reported.
 
Event Description
It was reported that a drug occlusion occurred.A 106x12cm ekosonic endovascular device was selected for use.Two ekosonic catheters were placed without problems.However, after transferring the patient to the intensive care unit, there was a lot of reflux.It was not possible to flush the drug line of the catheter.The drug lumen was occluded.The catheter was pulled but not replaced.The other ekosonic catheter continued without issue until the end of the procedure.No patient complications were reported.It was further reported that the patient's status was okay post procedure.However, the patient did not receive adequate lytic delivery as determined by the physician.
 
Event Description
It was reported that a drug occlusion occurred.A 106x12cm ekosonic endovascular device was selected for use.Two ekosonic catheters were placed without problems.However, after transferring the patient to the intensive care unit, there was a lot of reflux.It was not possible to flush the drug line of the catheter.The drug lumen was occluded.The catheter was pulled but not replaced.The other ekosonic catheter continued without issue until the end of the procedure.No patient complications were reported.It was further reported that the patient's status was okay post procedure.However, the patient did not receive adequate lytic delivery as determined by the physician.
 
Manufacturer Narrative
Device eval by manufacturer: the ekosonic endovascular device was returned for analysis.Microscopic visual inspection of the infusion catheter showed cracking on the drug port and coolant luer.Additionally, the device was tested for leaking, and the device leaked water from the drug port and coolant luer where the cracking was present.The reported events of obstruction within the device and difficulty flushing were unable to be confirmed because the cracking and leaking from the luers prevented any flow testing.
 
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 Key16820694
MDR Text Key314083358
Report Number2124215-2023-19856
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182324
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,Followup
Report Date 06/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-55112
Device Catalogue Number500-55112
Device Lot Number8035097938
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-