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

Model Number	109681-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): dxe, kra.
Event or Problem Description
It was reported loss of aspiration occurred.An angiojet solent omni catheter was selected for a fistula thrombectomy procedure.During loading the catheter over the wire, a bend/kink was noted in the middle of the catheter, and the wire was difficult to advance.A micro leak of the saline coming from the area of the kink, and a loss of aspiration was noted.The catheter was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b, pro code (product code): dxe, kra.Device evaluated by mfr: the device was returned for evaluation.Visual inspection of the returned device revealed two kinks on the catheter shaft at 43.2 and 62.1 cm distal to the strain relief.No other abnormalities were found.A functional test was performed, and the catheter was able to be primed and run, however the kink in the shaft at 62.1cm distal to the strain relief did have a fluid leak.No other issues were identified during the product analysis.
Event or Problem Description
It was reported loss of aspiration occurred.An angiojet solent omni catheter was selected for a fistula thrombectomy procedure.During loading the catheter over the wire, a bend/kink was noted in the middle of the catheter, and the wire was difficult to advance.A micro leak of the saline coming from the area of the kink, and a loss of aspiration was noted.The catheter was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24214428
• Report Number: 2124215-2026-05320
• Device Sequence Number: 9385399
• Product Code: DXE
• UDI-Device Identifier: 08714729889663
• UDI-Public: (01)08714729889663(17)270816(10)37931791
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: 109681-001
• Device Catalogue Number: 109681-001
• Device Lot Number: 0037931791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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