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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45031
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
Date of birth: (b)(6).
 
Event Description
It was reported that the procedure was cancelled after the patient had been sedated.An angiojet solent omni catheter was selected for a thrombectomy procedure.During preparation, it was noted that there was saline leaking from the pump.The patient was already sedated and the procedure was cancelled.No patient complications were reported.The patient's condition was stable but it was critical for her condition to do the procedure.It did not go through and the patient was moved to a different department for observation.
 
Manufacturer Narrative
A2 date of birth: (b)(6) 1998.Device evaluated by mfr.: returned product consisted of the solent omni thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually inspected.Inspection presented no damage or irregularities to the pump assembly or any other part of the device.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy mode.The device ran within normal range without any leaks from the pump assembly or anywhere else on the device and there were no errors/alarms from the console.
 
Event Description
It was reported that the procedure was cancelled after the patient had been sedated.An angiojet solent omni catheter was selected for a thrombectomy procedure.During preparation, it was noted that there was saline leaking from the pump.The patient was already sedated and the procedure was cancelled.No patient complications were reported.The patient's condition was stable but it was critical for her condition to do the procedure.It did not go through and the patient was moved to a different department for observation.
 
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Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10741928
MDR Text Key213254218
Report Number2134265-2020-14793
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/12/2022
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0025338443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Initial Date Manufacturer Received 10/11/2020
Initial Date FDA Received10/27/2020
Supplement Dates Manufacturer Received11/12/2020
Supplement Dates FDA Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age22 YR
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