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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 Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2023
Event Type  malfunction  
Event Description
It was reported that guidewire entrapment occurred.The target lesion was located in a non-tortuous, completely thrombosed superficial femoral artery.An angiojet solent omni thrombectomy catheter was selected for a thrombectomy procedure.The guidewire used was a non-boston scientific (bsc) guidewire.At the start of the procedure, everything went smoothly; however, at one point during the procedure, a lot of resistance was felt.The physician withdrew the catheter and tried, after inspection, to load the catheter on the wire again.It looked like the catheter got stuck on the wire.The physician withdrew the catheter again, and a slight buckle and kink in the proximal and middle portions of the catheter were observed.The wire did not go into the hub anymore, and it looked like the hydrophilic coating was damaged.The wire and the catheter were removed as one unit, and with some force, the wire was able to be removed from the catheter outside of the patient.The procedure was completed with a new non-bsc guidewire and a new angiojet solent omni thrombectomy catheter.
 
Manufacturer Narrative
Device evaluation by manufacturer: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.Media was returned in the form of photos.The photos were reviewed which showed only the device packaging.No complaint information from the photos aided in the analysis of the complaint.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.No guidewire was received with the device.A.035 guidewire was used to verify functionality of the device per the instructions for use.The guidewire was inserted into the wire lumen and passed through the tip of the device with slight resistance at the severe kink located at 24.5 cm from the tip and retracted with no issues.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for any issues related to the alleged complaint, however, product analysis found damage that could have contributed to the reported event.The complaint was not confirmed for any guidewire issues and passed through the device.
 
Event Description
It was reported that guidewire entrapment occurred.The target lesion was located in a non-tortuous, completely thrombosed superficial femoral artery.An angiojet solent omni thrombectomy catheter was selected for a thrombectomy procedure.The guidewire used was a non-boston scientific (bsc) guidewire.At the start of the procedure, everything went smoothly; however, at one point during the procedure, a lot of resistance was felt.The physician withdrew the catheter and tried, after inspection, to load the catheter on the wire again.It looked like the catheter got stuck on the wire.The physician withdrew the catheter again, and a slight buckle and kink in the proximal and middle portions of the catheter were observed.The wire did not go into the hub anymore, and it looked like the hydrophilic coating was damaged.The wire and the catheter were removed as one unit, and with some force, the wire was able to be removed from the catheter outside of the patient.The procedure was completed with a new non-bsc guidewire and a new angiojet solent omni thrombectomy catheter.
 
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Brand Name
ANGIOJET SOLENT OMNI
Type of Device
CATHETER, EMBOLECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17971531
MDR Text Key326258709
Report Number2124215-2023-57578
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/14/2023
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
Device Lot Number0032032756
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2023
Initial Date FDA Received10/19/2023
Supplement Dates Manufacturer Received11/02/2023
Supplement Dates FDA Received11/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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