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

Model Number	112266-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.G1: mfr site address 1- (b)(6).
Event or Problem Description
It was reported the patient experienced a vascular perforation.The 95% stenosed target lesion was located in a moderately tortuous and severely calcified left superficial femoral artery (sfa).A 2.4mm jetstream xc catheter was selected for a percutaneous transluminal angioplasty (pta) procedure to treat peripheral artery disease (pad).During the procedure, the 2.4mm jetstream xc catheter functioned as expected.When imaging was used to confirm treatment, a vascular perforation was observed.An unknown-brand stent was placed to treat this patient complication and hemostasis was confirmed so the procedure was completed.
Additional Manufacturer Narrative
A2 - age at time of event: additional information received identified patient was in his 60s (years) at the time of the event.B5: updated with additional information.G1: mfr site address 1- business & technology park, model farm road.E1 - initial reporter city: (b)(6).Detailed product information was not provided to bsc as the account did not have the available information.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.
Event or Problem Description
It was reported the patient experienced a vascular perforation.The 95% stenosed target lesion was located in a moderately tortuous and severely calcified left superficial femoral artery (sfa).A 2.4mm jetstream xc catheter was selected for a percutaneous transluminal angioplasty (pta) procedure to treat peripheral artery disease (pad).During the procedure, the 2.4mm jetstream xc catheter functioned as expected.When imaging was used to confirm treatment, a vascular perforation was observed.An unknown-brand stent was placed to treat this patient complication and hemostasis was confirmed so the procedure was completed.It was further reported that the patient had intermittent claudication of the left lower extremity with rutherford stage iii classification.An endovascular thrombectomy (evt) procedure was performed on the affected side with an ankle-brachial index (abi) of 0.70.During a computed tomography (ct) procedure, intravascular ultrasound (ivus) indicated the affected area required debulking, so an unknow-brand catheter was used.The unknow-brand catheter was followed by a 2.4mm jetstream xc catheter to treat the patient.A vascular perforation was noted, and hemostasis was attempted for 15 minutes with a 5.0mm unknown-brand balloon, which was unsuccessful, so a non-boston scientific stent was placed.

• Brand Name: JETSTREAM? XC
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23497368
• Report Number: 2124215-2025-80761
• Device Sequence Number: 8867675
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 112266-001
• Device Catalogue Number: 112266-001
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 02/07/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE MEDICAL VIABAHN STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male