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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X12CM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55112
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2023
Event Type  malfunction  
Event Description
It was reported that the lytic therapy would not infuse.During a bilateral ekos case, two ekos+ devices were inserted into the patient.When the ekos+ kit 106cm 12 cm was hooked up to infuse lytic, the drug would not infuse.The drug line was aspirated in an attempt to troubleshoot the issue.The ekos+ device was replaced with an ekosonic endovascular device, 106x12cm to troubleshoot the issue, but the new ekosonic device would not infuse lytic.Once again, the drug line was aspirated in an attempt to troubleshoot the issue.As a result of the device malfunction, the physician elected to remove the ekosonic endovascular device, and the patient was transferred to the icu with only one ekos+ device in place.It was unknown whether the patient received the correct dose of lytic therapy.However, there was no reported undesirable patient outcome.
 
Manufacturer Narrative
Device analysis: the drug lumen was hooked up to a non-boston scientific infusion pump and ran for a sustained 30 minutes of infusion.No pump error alarms were noticed.A syringe filled with blue dye was attached to the drug luer and flushed through the catheter under water.The blue dye was able to be seen coming from the drug holes and confirmed the ability of the device to be flushed.The reported event of obstruction within the drug line was unable to be confirmed.
 
Event Description
It was reported that the lytic therapy would not infuse.During a bilateral ekos case, two ekos+ devices were inserted into the patient.When the ekos+ kit 106cm 12 cm was hooked up to infuse lytic, the drug would not infuse.The drug line was aspirated in an attempt to troubleshoot the issue.The ekos+ device was replaced with an ekosonic endovascular device, 106x12cm to troubleshoot the issue, but the new ekosonic device would not infuse lytic.Once again, the drug line was aspirated in an attempt to troubleshoot the issue.As a result of the device malfunction, the physician elected to remove the ekosonic endovascular device, and the patient was transferred to the icu with only one ekos+ device in place.It was unknown whether the patient received the correct dose of lytic therapy.However, there was no reported undesirable patient outcome.
 
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Brand Name
EKOSONIC 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 Key17856955
MDR Text Key324778152
Report Number2124215-2023-54030
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public00858593006134
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2023
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 Number8035092217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EKOS+ KIT 106CM 12 CM; EKOS+ KIT 106CM 12 CM
Patient SexFemale
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