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

Model Number	109681-001
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent omni was selected for use in a thrombectomy procedure.During withdrawal, it was noted that a catheter break occurred.The procedure was completed using this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): kra.
Additional Manufacturer Narrative
D2b - pro code (product code): kra.Device evaluated by mfr: the device was returned for evaluation.The device revealed multiple shaft kinks and buckling of the outer shaft.Microscope examination revealed a hypotube separation was observed located at 1 cm from the tip along with shaft buckling, stretching and kinks.No other issues were identified with the device.
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent omni was selected for use in a thrombectomy procedure.During withdrawal, it was noted that a catheter break occurred.The procedure was completed using this 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: 21710123
• Report Number: 2124215-2025-14855
• Device Sequence Number: 18629996
• Product Code: DXE
• UDI-Device Identifier: 08714729889663
• UDI-Public: (01)08714729889663(17)260713(10)35141565
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/09/2025

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: 07/13/2026
• Device Model Number: 109681-001
• Device Catalogue Number: 109681-001
• Device Lot Number: 0035141565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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