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

Model Number	112266-001
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).
Event or Problem Description
It was reported material deformation occurred on the device.A 1.85mm jetstream sc catheter was selected for a procedure to treat a moderately tortuous, severely calcified and 99% stenosed target lesion inside the superficial femoral artery (sfa).During the procedure, loss of rotation occurred with the 1.85mm jetstream sc catheter.The 1.85mm jetstream sc catheter was removed and replaced with a 1.6 mm jetstream sc catheter that was used successfully inside of the patient.Then, 2.4mm jetstream xc catheter was successfully primed and used inside of the patient; however, a balloon-like deformation occurred on the device approximately 10 cm from the tip of the device.The functions of the 2.4mm jetstream xc catheter were unaffected and the 2.4mm jetstream xc catheter was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).Device evaluation by manufacturer: the returned product to boston scientific consisted of a jetstream catheter.During analysis the device was connected to the console per the ifu.Functional analysis of the device was completed, and it was noted that the blades were not spinning.The device was visually and microscopically inspected for damage.Visual inspection revealed damage at 1cm from the tip causing the blades to not spin.It was also found that during the functional testing the shaft about 5cm from the tip had a bubble-like formation.
Event or Problem Description
It was reported material deformation occurred on the device.A 1.85mm jetstream sc catheter was selected for a procedure to treat a moderately tortuous, severely calcified and 99% stenosed target lesion inside the superficial femoral artery (sfa).During the procedure, loss of rotation occurred with the 1.85mm jetstream sc catheter.The 1.85mm jetstream sc catheter was removed and replaced with a 1.6 mm jetstream sc catheter that was used successfully inside of the patient.Then, 2.4mm jetstream xc catheter was successfully primed and used inside of the patient; however, a balloon-like deformation occurred on the device approximately 10 cm from the tip of the device.The functions of the 2.4mm jetstream xc catheter were unaffected and the 2.4mm jetstream xc catheter was used to complete the procedure.There were no patient complications as a result of this event.

• 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 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: 24140556
• Report Number: 2124215-2026-03929
• Device Sequence Number: 9502197
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271031(10)37586884
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Model Number: 112266-001
• Device Catalogue Number: 112266-001
• Device Lot Number: 0037586884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.6 MM JETSTREAM SC CATHETER; 1.6 MM JETSTREAM SC CATHETER; 1.85MM JETSTREAM SC CATHETER; 1.85MM JETSTREAM SC CATHETER
• Patient Sex: Unknown