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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 Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  malfunction  
Event Description
It was reported there was a labeling issue.A 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
 
Manufacturer Narrative
Device analysis: the ekosonic ultrasonic core (usc) and ekosonic infusion catheter (ic) were returned to boston scientific for analysis.The device was visually inspected for damage and none was noted.The length of the ic measured 107.70 cm, meeting specification.The length of the usc measured usc measurement: 140.60 cm, which does not meet specification for a 106 cm usc.Instead this met specification for a 135cm usc, which confirmed the reported event.The usc was inserted in to the ic and the usc extended 24.60 cm past the distal tip of the ic.The catheter was connected to the control unit and the system information screen confirmed the reported serial number as well as listed the device as a 106cm length with a 12 cm treatment zone.The catheter was placed in a water bath with a temperature of 37c and therapy was then started on the control unit.Approximately, two minutes into treatment, an e006 (channel cross connection) alert occurred.This alarm was dismissed and followed by another e006 alert.Therapy was stopped and the system was then shut down to conclude functional testing.
 
Event Description
It was reported there was a labeling issue.A 106x12cm ekosonic endovascular device (ekos) was selected for use in a pulmonary embolism (pe) procedure.When the physician tried to place the ultrasonic core wire in the patient, it was realized that something was wrong.The device was removed from the patient and was measured.The ultrasonic core wire measured 135cm.The device was exchanged and found the second box had the same issue.The device was then exchanged again, and treatment proceeded.
 
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Brand Name
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14733405
MDR Text Key295818478
Report Number2134265-2022-06527
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public00858593006134
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2022
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 Number8035075225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberREMOVAL # 92887566-FA
Patient Sequence Number1
Patient SexMale
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