MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY

Model Number	45031
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter stuck on wire.The target lesion was located at the left distal superior femoral artery (sfa).An angiojet solent dista catheter was advanced for thrombectomy procedure.During the procedure, the catheter became entrapped on a non-bsc guidewire.The catheter was unable to be removed so the patient was transferred from the vascular lab to a different room to perform a possible cutdown of bilateral groins.However, the physician was ultimately able to perform a controlled removal of the guidewire, catheter and sheath under general anesthesia without a cutdown.It was removed under fluoroscopic guidance.There were no patient complications.
Additional Manufacturer Narrative
D4 - lot number: updated device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.The pump assembly and effluent/supply line were completely removed and missing from the returned device.The shaft, tip, and hub/manifold were visually examined for damage or any irregularities.The catheter shaft showed severe damage included multiple bends/kinks, buckling along the entire shaft and guide sheathe fracture.The device was received with a.035 glidewire advantage guidewire inside the device.The complaint was confirmed for guidewire issues related to severe shaft damage.
Event or Problem Description
It was reported that catheter stuck on wire.The target lesion was located at the left distal superior femoral artery (sfa).An angiojet solent dista catheter was advanced for thrombectomy procedure.During the procedure, the catheter became entrapped on a non-bsc guidewire.The catheter was unable to be removed so the patient was transferred from the vascular lab to a different room to perform a possible cutdown of bilateral groins.However, the physician was ultimately able to perform a controlled removal of the guidewire, catheter and sheath under general anesthesia without a cutdown.It was removed under fluoroscopic guidance.There were no patient complications.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: 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 Key: 17596365
• Report Number: 2124215-2023-44905
• Device Sequence Number: 11821263
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0030769135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown