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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 Display or Visual Feedback Problem (1184); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
It was reported that shaft damage occurred.The target lesion was located in the superficial femoral artery.An angiojet solent omni was used in a thrombectomy procedure.During the procedure while trying to use thrombectomy mode, the screen showed an error message and device did not work.The catheter was removed from the patient's body and found that the wire was protruding through the catheter's shaft.The procedure was completed with a different device.No patient complications were reported and patient is fine.
 
Event Description
It was reported that shaft damage occurred.The target lesion was located in the superficial femoral artery.An angiojet solent omni was used in a thrombectomy procedure.During the procedure while trying to use thrombectomy mode, the screen showed an error message and device did not work.The catheter was removed from the patient's body and found that the wire was protruding through the catheter's shaft.The procedure was completed with a different device.No patient complications were reported and patient is fine.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.There was severe tip damage and stretching.There was a broken hypotube located from the tip to 3cm proximal.Functional testing could not be completed due to the severe damage on the catheter shaft.No pressure reading could be reported.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
 
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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 Key12013680
MDR Text Key256714014
Report Number2134265-2021-07701
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 07/15/2021
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 Date08/23/2022
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0026258871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2021
Initial Date Manufacturer Received 05/24/2021
Initial Date FDA Received06/16/2021
Supplement Dates Manufacturer Received06/24/2021
Supplement Dates FDA Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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