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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 Break (1069)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event - used the first day of the month of the aware date since no exact date provided.
 
Event Description
It was reported that catheter break occurred.The target lesion was located in the superior mesenteric artery (sma).An angiojet solent omni catheter was selected for a thrombectomy procedure.The catheter was advanced beyond the thrombus in the sma.During procedure, a loud pop was heard and found that the catheter was broken.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that catheter break occurred.The target lesion was located in the superior mesenteric artery (sma).An angiojet solent omni catheter was selected for a thrombectomy procedure.The catheter was advanced beyond the thrombus in the sma.During procedure, a loud pop was heard and found that the catheter was broken.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
B3 - date of event - used the first day of the month of the aware date since no exact date provided.G1 - manufacturing address corrected.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 shaft showed 1 kink located 64.5cm from the tip.Functional testing was competed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed and was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.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 Key11177783
MDR Text Key227068916
Report Number2134265-2021-00324
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
PMA/PMN Number
K111182
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/02/2021
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 Model Number45031
Device Catalogue Number45031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Initial Date Manufacturer Received 01/05/2021
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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