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

Model Number	112266-001
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.A 2.4 mm jetstream? xc atherectomy catheter was used during a superficial femoral artery angiogram procedure to treat a moderately calcified, moderately tortuous lesion with 60% stenosis.Following successful use of the catheter, the device could not be removed and was stretched proximal to the infusion ports.The catheter was manually removed by pulling from the patient in one piece.There were no patient complications, and the patient fully recovered.

• 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: 25659545
• Report Number: 2124215-2026-34588
• Device Sequence Number: 16047111
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)280409(10)38795674
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 06/29/2026

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: 0038795674
• 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: 06/17/2026
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 03/10/2026
• 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
• Patient Sex: Unknown