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	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported material separation occurred with the device.The 70% stenosed, mildly calcified and tortuous lesion was located in the peripheral artery.A jetstream? xc was selected for a lower extremity angiogram procedure to treat peripheral artery disease (pad).During the procedure, a segment of the outer tubing material of the device separated.The portion of the device was outside of the patient's body at the time of the material separation.The device was removed intact.A different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported material separation occurred with the device.The 70% stenosed, mildly calcified and tortuous lesion was located in the peripheral artery.A jetstream? xc was selected for a lower extremity angiogram procedure to treat peripheral artery disease (pad).During the procedure, a segment of the outer tubing material of the device separated.The portion of the device was outside of the patient's body at the time of the material separation.The device was removed intact.A different device of the same model was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the returned device consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual examination revealed multiple kinks, and the shaft burst 13 cm from the strain relief.Microscopic examination revealed no damage.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the shaft burst.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion: boston scientific concludes the most probable root cause as 'unintended use error caused or contributed to 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24586447
• Report Number: 2124215-2026-13910
• Device Sequence Number: 21176597
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271213(10)37935438
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 0037935438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2025
• 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
• Patient Sex: Unknown