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

Model Number	109676-001
Medical Device Problem Codes	Suction Problem (2170); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code- dxe, kra.
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet solent proxi was selected for treatment.During the procedure, the device was used but failed to provide suction.The machine was restarted, and both catheters were re-primed, but the issue persisted.The procedure was completed with a different device.Thee were no patient complications reported.
Additional Manufacturer Narrative
D2b: pro code- dxe, kra.
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet solent proxi was selected for treatment.During the procedure, the device was used but failed to provide suction.The machine was restarted, and both catheters were re-primed, but the issue persisted.The procedure was completed with a different device.There were no patient complications reported.It was further reported that the angiojet failed to read the catheters that were being inserted.The device did not continue to pump or infuse saline after aspiration was lost.The system failed to read catheters and would not advance past that phase and was in thrombectomy mode by default.No visible defects, such as leaks, breaks, or kinks, were observed during the incident.There were no issues noted with any specific part of the device, such as the pump, mid-shaft, tubing, or luer.

• Brand Name: ANGIOJET SOLENT PROXI
• 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: 20675595
• Report Number: 2124215-2024-70625
• Device Sequence Number: 12999308
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• 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): 12/02/2024

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: 05/17/2026
• Device Model Number: 109676-001
• Device Catalogue Number: 109676-001
• Device Lot Number: 0034484603
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 06/17/2024
• 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