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

Model Number	112266-001
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device material separated inside of the patient.The moderately calcified, and moderately tortuous occlusion was located in the superficial femoral artery (sfa).A 2.4mm jetstream xc catheter was selected for an angiogram to treat the occlusion.During the procedure, the catheter became stuck at a bifurcation inside of the patient and the catheter broke when being removed.The catheter was able to be removed in one piece from inside of the patient, and an alternate device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device history records (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.Device technical analysis: this jetstream xc catheter was returned for analysis.Visual and microscopic inspection was performed for any shaft damage.The device's catheter shaft showed no damage.The device was set-up and functionally tested per the instructions for use.The device was connected to the test console and the device primed and ran as designed.The device was tested for a period of 1 minute with no alarms or errors.Inspection of the remainder of the device revealed no damage or irregularities.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion: boston scientific concludes the most probable root cause as 'no problem detected'.There was no indication the device was damaged prior to use.Analysis of the device showed no shaft damage.The device was set up and functionally tested per the ifu.There were no issues with the set-up or the priming of the device.
Event or Problem Description
It was reported the device material separated inside of the patient.The moderately calcified, and moderately tortuous occlusion was located in the superficial femoral artery (sfa).A 2.4mm jetstream xc catheter was selected for an angiogram to treat the occlusion.During the procedure, the catheter became stuck at a bifurcation inside of the patient and the catheter broke when being removed.The catheter was removed in one piece from inside of the patient, and an alternate device was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 23834076
• Report Number: 2124215-2025-91613
• Device Sequence Number: 8954599
• Product Code: MCW
• UDI-Device Identifier: 08714729889922
• UDI-Public: (01)08714729889922(17)271031(10)37587084
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 0037587084
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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: MEDTRONIC SPIDERFX; MEDTRONIC SPIDERFX
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG