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

Model Number	112264-001
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919); Noise, Audible (3273)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was required in this event.The 95% stenosed, occluded vessel was located in the superficial femoral artery (sfa).A jetstream? xc catheter was selected for use in an atherectomy procedure intended to treat the occluded vessel.During advancement toward the target lesion, the device was unable to progress as expected and an audible noise was noted.The device was subsequently removed from the patient.Upon removal, a pre-existing unknown-brand covered stent was noted to be attached to the device.A thrombectomy procedure was attempted to address the resulting condition, and a bypass procedure was then performed to restore blood flow.The patient was transferred to the intensive care unit (icu) afterwards for recovery.
Event or Problem Description
It was reported that additional intervention was required in this event.The 95% stenosed, occluded vessel was located in the superficial femoral artery (sfa).A jetstream? xc catheter was selected for use in an atherectomy procedure intended to treat the occluded vessel.During advancement toward the target lesion, the device was unable to progress as expected and an audible noise was noted.The device was subsequently removed from the patient.Upon removal, a pre-existing unknown-brand covered stent was noted to be attached to the device.A thrombectomy procedure was attempted to address the resulting condition, and a bypass procedure was then performed to restore blood flow.The patient was transferred to the intensive care unit (icu) afterwards for recovery.
Additional Manufacturer Narrative
Investigation results: inspection of the returned jetstream revealed no damage.The complaint was not confirmed as there was no damage, and the device was able to function as intended.Device analysis findings: the returned product that was received by boston scientific consisted of a jetstream atherectomy catheter.Visual and microscopic inspection was completed.Visual and microscopic examinations revealed no damage.The device was functionally tested, and it was able to prime and then run without any issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device.Device history record (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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 'no problem detected'.

• 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: 24758121
• Report Number: 2124215-2026-17990
• Device Sequence Number: 9101126
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)271201(10)37843247
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/21/2026

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: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0037843247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female