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

Model Number	112264-001
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	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the material of the device peeled.A 2.1mm jetstream xc catheter was selected to treat peripheral artery disease (pad) in a 100% stenosed, and mildly calcified target area in the peripheral artery.During the procedure, the material of the 2.1 mm jetstream xc catheter began to peel at the back end of the catheter.The original 2.1 mm jetstream xc catheter was used to complete the procedure.The 2.1 mm jetstream xc catheter was removed from the patient and there were no patient complications as a result of this event.
Event or Problem Description
It was reported the material of the device peeled.A 2.1mm jetstream xc catheter was selected to treat peripheral artery disease (pad) in a 100% stenosed, and mildly calcified target area in the peripheral artery.During the procedure, the material of the 2.1 mm jetstream xc catheter began to peel at the back end of the catheter.The original 2.1 mm jetstream xc catheter was used to complete the procedure.The 2.1 mm jetstream xc catheter was removed from the patient and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device returned 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 94cm from the tip.Microscopic examination revealed no damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis confirmed the shaft burst.

• 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: 23134238
• Report Number: 2124215-2025-67191
• Device Sequence Number: 9857658
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)270822(10)37026222
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/21/2025

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: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0037026222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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