MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM? SC; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	112262-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Perforation of Vessels (2135); Pseudoaneurysm (2605)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aneurysm occurred, requiring intervention.The target lesion was located in the opening of the superficial femoral artery.A 1.85mm jetstream sc atherectomy catheter was used, followed by two 2.1mm jetstream xc atherectomy catheters for an endovascular therapy procedure to treat restenosis.During the procedure, the lesion was scraped down to the adventitia, which resulted in an aneurysm.Endarterectomy and vascular repair were required to resolve the aneurysm.The patient was reported to be in recovery.
Event or Problem Description
It was reported that an aneurysm occurred, requiring intervention.The target lesion was located in the opening of the superficial femoral artery.A 1.85mm jetstream sc atherectomy catheter was used, followed by two 2.1mm jetstream xc atherectomy catheters for an endovascular therapy procedure to treat restenosis.During the procedure, the lesion was scraped down to the adventitia, which resulted in an aneurysm.Endarterectomy and vascular repair were required to resolve the aneurysm.The patient was reported to be in recovery.It was further reported that the vessel trauma was found during a surgery for restenosis at the treatment site performed on (b)(6) 2023.
Event or Problem Description
It was reported that an aneurysm occurred, requiring intervention.The target lesion was located in the opening of the superficial femoral artery.A 1.85mm jetstream sc atherectomy catheter was used, followed by two 2.1mm jetstream xc atherectomy catheters for an endovascular therapy procedure to treat restenosis.During the procedure, the lesion was scraped down to the adventitia, which resulted in an aneurysm.Endarterectomy and vascular repair were required to resolve the aneurysm.The patient was reported to be in recovery.It was further reported that the vessel trauma was found during a surgery for restenosis at the treatment site performed on (b)(6) 2023.It was further reported that it could not be confirmed what type of vessel trauma occurred.
Additional Manufacturer Narrative
H6.Patient code was updated.
Event or Problem Description
It was reported that an aneurysm occurred, requiring intervention.The target lesion was located in the opening of the superficial femoral artery.A 1.85mm jetstream sc atherectomy catheter was used, followed by two 2.1mm jetstream xc atherectomy catheters for an endovascular therapy (evt) procedure to treat restenosis.During the procedure, the lesion was scraped down to the adventitia, which resulted in an aneurysm.Endarterectomy and vascular repair were required to resolve the aneurysm.The patient was reported to be in recovery.It was further reported that the vessel trauma was found during a surgery for restenosis at the treatment site performed on (b)(6) 2023.It was again further report that on (b)(6) 2023, restenosis of the right sfa was suspected.On (b)(6) 2023, repeat evt was performed with the jetstream sc atherectomy catheter, during which the pseudoaneurysm was identified on angiography.
Additional Manufacturer Narrative
B3: date of event updated to be the date the pseudoaneurysm occurred.H6: patient code updated.
Additional Manufacturer Narrative
H10: related report number corrected.
Event or Problem Description
It was reported that an aneurysm occurred, requiring intervention.The target lesion was located in the opening of the superficial femoral artery.A 1.85mm jetstream sc atherectomy catheter was used, followed by two 2.1mm jetstream xc atherectomy catheters for an endovascular therapy (evt) procedure to treat restenosis.During the procedure, the lesion was scraped down to the adventitia, which resulted in an aneurysm.Endarterectomy and vascular repair were required to resolve the aneurysm.The patient was reported to be in recovery.It was further reported that the vessel trauma was found during a surgery for restenosis at the treatment site performed on (b)(6) 2023.It was again further report that on (b)(6) 2023, restenosis of the right sfa was suspected.On (b)(6) 2023, repeat evt was performed with the jetstream sc atherectomy catheter, during which the pseudoaneurysm was identified on angiography.It was further reported that this event is a duplicate to the event reported in 2124215-2023-62507.

• Brand Name: JETSTREAM? SC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18457340
• Report Number: 2124215-2023-75099
• Device Sequence Number: 3088047
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)240328(10)29303323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: 112262-001
• Device Catalogue Number: 112262-001
• Device Lot Number: 0029303323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 01/14/2024; 01/14/2024; 11/25/2025; 12/09/2025
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/01/2024; 02/09/2024; 12/08/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female