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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 Leak/Splash (1354); Suction Problem (2170); Material Perforation (2205)
Patient Problem Insufficient Information (4580)
Event Date 05/09/2021
Event Type  malfunction  
Event Description
It was reported that loss of aspiration occurred.The target lesion was located in the acute arterial occluded right lower limb.An angiojet solent omni was advanced for treatment.During the procedure, loss of aspiration was observed at a certain moment following a superficial femoral artery.The catheter was removed and a leak was noted with perforation in the catheter's middle segment.The catheter was then unable to finish satisfactory aspiration of the arterial segments.
 
Manufacturer Narrative
Device evaluated by mfr the product return contained an angiojet solent omni.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The catheter shaft showed multiple kinks.A functional test was performed per device preparation.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product, with an average pressure.During functional testing, the shaft leak was confirmed, and measured to be at a kink located at 82.5 cm from the tip.Review of the shaft under microscope revealed that the kink and damage at the location caused a puncture in the polymer, which resulted in the leak.
 
Event Description
It was reported that loss of aspiration occurred.The target lesion was located in the acute arterial occluded right lower limb.An angiojet solent omni was advanced for treatment.During the procedure, loss of aspiration was observed at a certain moment following a superficial femoral artery.The catheter was removed and a leak was noted with perforation in the catheter's middle segment.The catheter was then unable to finish satisfactory aspiration of the arterial segments.
 
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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 Key11924553
MDR Text Key254327388
Report Number2134265-2021-07134
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 09/24/2021
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 Date08/30/2022
Device Model Number45031
Device Catalogue Number45031
Device Lot Number0026187174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Initial Date Manufacturer Received 05/10/2021
Initial Date FDA Received06/02/2021
Supplement Dates Manufacturer Received09/02/2021
Supplement Dates FDA Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
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