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 Code	Perforation of Vessels (2135)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vessel rupture occurred, requiring an additional device.A 1.85mm jetstream sc catheter was selected for an endovascular therapy procedure in a superficial femoral artery (sfa).The sfa calcified lesion was ablated using the jetstream, which resulted in vascular rupture.The device was able to be removed as usual.After that, a non-boston scientific stent was implanted, and hemostasis was successfully achieved.

• 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: 23647197
• Report Number: 2124215-2025-86446
• Device Sequence Number: 9961771
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)271020(10)37493393
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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 Model Number: 112262-001
• Device Catalogue Number: 112262-001
• Device Lot Number: 0037493393
• 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: 11/01/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 09/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown