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

Model Number	111303-001
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that procedure was cancelled.An angiojet solent dista solent dista catheter was selected for use.However, during the procedure, it was noted that the became kinked and a saline error message displayed.Another angiojet solent dista was selected.Consequently, the device stopped working due to an error message.The angiojet console was turned off and back on but that did not resolve the catheter error.The procedure was cancelled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): dxe, kra.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, patient information, and initial reporter, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: ANGIOJET? SOLENT? DISTA
• 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: 22994902
• Report Number: 2124215-2025-62493
• Device Sequence Number: 21104769
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: (01)08714729889731(17)260824(10)35069556
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• 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
• Report Date (Section B): 09/08/2025

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 Expiration Date: 08/24/2026
• Device Model Number: 111303-001
• Device Catalogue Number: 111303-001
• Device Lot Number: 0035069556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 09/24/2024
• 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