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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY Back to Search Results
Model Number 45030
Device Problems Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Patient Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2020
Event Type  Injury  
Manufacturer Narrative
Date of event was approximated from aware date as event date was not reported.
 
Event Description
It was reported that the catheter was difficult to remove and detached.The patient presented with severe acute onset of decreased blood supply to the right leg with amputation potential.An angiojet solent dista was selected for a thrombectomy procedure and was advanced over a guidewire.The device became stuck in the distal right anterior tibial artery.The device was not pulled back over the wire nor with the wire at this time.Then, a lot of force was used to pull the catheter out of the body and the catheter detached into two pieces.The fragment within the body was visible in imaging as it had a marker.Micro pliers were used to remove the detached fragment.No further fragment was visible on imaging.During removal, the catheter had become elongated and it was difficult to see if there was any other detached component.A thrombolysis catheter was inserted and infusion initiated.There was no indication of any remaining angiojet device fragment during this portion of the procedure.It was further decided that the leg was not salvageable, infusion canceled, and amputation planned.The patient was then transferred to another hospital for amputation operation.
 
Event Description
It was reported that the catheter was difficult to remove and detached.The patient presented with severe acute onset of decreased blood supply to the right leg with amputation potential.An angiojet solent dista was selected for a thrombectomy procedure and was advanced over a guidewire.The device became stuck in the distal right anterior tibial artery.The device was not pulled back over the wire nor with the wire at this time.Then, a lot of force was used to pull the catheter out of the body and the catheter detached into two pieces.The fragment within the body was visible in imaging as it had a marker.Micro pliers were used to remove the detached fragment.No further fragment was visible on imaging.During removal, the catheter had become elongated and it was difficult to see if there was any other detached component.A thrombolysis catheter was inserted and infusion initiated.There was no indication of any remaining angiojet device fragment during this portion of the procedure.It was further decided that the leg was not salvageable, infusion canceled, and amputation planned.The patient was then transferred to another hospital for amputation operation.It was further reported that the patient presented for the thrombectomy procedure with a salvageable limb.The thrombus started a few centimeters (cm) above the knee and into all three leg vessels.The anatomy was not tortuous, however, a 3cmx7cm popliteal aneurysm was present.There was no calcification seen and the thrombus led to complete occlusion.During the procedure, the wire was not possible to move and the angiojet solent dista was not possible to move over the wire.Because of the possible truncation of the thrombectomy catheter, it was not possible to retrieve it from the non-boston scientific sheath.When removed with more force, the angiojet solent dista started to elongate and then detached.During x-ray imaging, no further component was observed.There was no vessel trauma observed during the procedure.The patient had no new symptoms initially.A few hours later in the intensive care unit during catheter directed thrombolysis, there were signs of thrombus progression and need of amputation.Amputation was performed at the high femoral.During amputation, approximately 40cm of the device was retrieved from the femoral artery.After retrieving the proximal and the distal parts of the angiojet solent dista, the 55cm 5fr sheath over a wire was exchanged with a 23cm 7fr.A third part of the angiojet solent dista was found inside the 5fr sheath and it was possible to traverse with a wire without noticing.It then stayed in the vessel when the 5fr sheath was exchanged.
 
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Brand Name
ANGIOJET SOLENT DISTA
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10817100
MDR Text Key215520791
Report Number2134265-2020-15611
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,foreig
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/12/2022
Device Model Number45030
Device Catalogue Number45030
Device Lot Number0025906074
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/30/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received11/12/2020
Supplement Dates FDA Received11/30/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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