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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 Problems Defective Device (2588); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/26/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled after the patient had been sedated.The target lesion was located in the femoral popliteal artery.An angiojet solent omni catheter was selected for a thrombectomy procedure.During preparation, it was noted that the console showed an error message indicating unable to read pump barcode.Tried again multiple times but still the console was unable to read the barcode.The patient was already sedated and procedure was cancelled.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the solent omni thrombectomy.The barcode, waste bag, pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.When received, the device had fluid in the waste bag, boot, and device indicating that the barcode read and went into prime.Inspection of the device presented no damage to the barcode or device.Functional testing was performed by placing the device in the console.The barcode was able to be read instantly with no issues or difficulties and was able to go int prime with no errors or issues.
 
Event Description
It was reported that the procedure was cancelled after the patient had been sedated.The target lesion was located in the femoral popliteal artery.An angiojet solent omni catheter was selected for a thrombectomy procedure.During preparation, it was noted that the console showed an error message indicating unable to read pump barcode.Tried again multiple times but still the console was unable to read the barcode.The patient was already sedated and procedure was cancelled.No patient complications were reported.
 
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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 Key10817079
MDR Text Key215520463
Report Number2134265-2020-15538
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 12/18/2020
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 Date08/05/2021
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0024523486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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