MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM? SC; Catheter, Peripheral, Atherectomy

Model Number	112260-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became entrapped with the guidewire.A 1.6 mm jetstream? sc catheter was used during an endovascular therapy procedure to treat a severely calcified, moderately tortuous superficial femoral artery with 100% stenosis.After successful atherectomy, resistance was encountered during device removal due to the catheter became stuck on a thruway 0.014 guidewire.The device and guidewire were withdrawn together and gradually removed from the patient.Once outside the patient, the jetstream catheter was able to be removed from the guidewire by applying significant force.There were no patient complications as a result of this event.

• Brand Name: JETSTREAM? SC
• 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 ; +1(763)494-1632
• MDR Report Key: 25692958
• Report Number: 2124215-2026-35489
• Device Sequence Number: 15903821
• Product Code: MCW
• UDI-Device Identifier: 08714729889830
• UDI-Public: (01)08714729889830(17)271123(10)37782446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 112260-001
• Device Catalogue Number: 112260-001
• Device Lot Number: 0037782446
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown