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

Model Number	112266-001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire sheared off during the use of this device, resulting in attempts to retrieve the fragment and pain to the patient.This 2.4mm jetstream xc catheter was selected for use during a jetstream atherectomy of in-stent restenosis of the left popliteal and left posterior tibial.During the procedure, the jetstream device was being used with a non-boston scientific guidewire and while using the jetstream device in the distal segment, the guidewire sheared off and was left in the patients left posterior tibial artery.It was noted that the jetstream device was possibly spinning in one segment longer than expected.The physician attempted for two hours to retrieve the distal end of the wire.The patient experienced discomfort/pain and received pain medication; however, it was noted that it may have been given for the patients overall health issues and being in the procedure for a longer period.
Additional Manufacturer Narrative
Further event and patient information was not provided to bsc.We completed a good faith effort to obtain additional information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Further event and patient information was not provided to bsc.We completed a good faith effort to obtain additional information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the guidewire sheared off during the use of this device, resulting in attempts to retrieve the fragment and pain to the patient.This 2.4mm jetstream xc catheter was selected for use during a jetstream atherectomy of in-stent restenosis of the left popliteal and left posterior tibial.During the procedure, the jetstream device was being used with a non-boston scientific guidewire and while using the jetstream device in the distal segment, the guidewire sheared off and was left in the patients left posterior tibial artery.It was noted that the jetstream device was possibly spinning in one segment longer than expected.The physician attempted for two hours to retrieve the distal end of the wire.The patient experienced discomfort/pain and received pain medication; however, it was noted that it may have been given for the patients overall health issues and being in the procedure for a longer period.

• 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: 23535509
• Report Number: 2124215-2025-81540
• Device Sequence Number: 10167699
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)270203(10)35549937
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0035549937
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 01/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK ROADRUNNER 300CM GUIDEWIRE; COOK ROADRUNNER 300CM GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White