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

Model Number	112262-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck on the embolic protection device (epd).A jetstream sc catheter, 1.85mm, was selected for use to treat stenosis in the superficial femoral artery (sfa).The target lesion was reported to be 100% stenosed with severe calcification.The jetstream was used in conjunction with a non-boston scientific epd.After using the jetstream for about 4.5 minutes, removal was attempted, however, the device became entrapped on the epd.Both the jetstream and epd were removed together as one unit.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the returned device consisted of a jetstream catheter with an unknown filter guidewire stuck inside.Visual examination revealed multiple points of buckling on the sheath.Microscopic examination revealed no further damages.Product analysis confirmed the device was stuck on a guidewire.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 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: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.
Event or Problem Description
It was reported that the device became stuck on the embolic protection device (epd).A jetstream sc catheter, 1.85mm, was selected for use to treat stenosis in the superficial femoral artery (sfa).The target lesion was reported to be 100% stenosed with severe calcification.The jetstream was used in conjunction with a non-boston scientific epd.After using the jetstream for about 4.5 minutes, removal was attempted, however, the device became entrapped on the epd.Both the jetstream and epd were removed together as one unit.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 ; 7634941632
• MDR Report Key: 24327778
• Report Number: 2124215-2026-08097
• Device Sequence Number: 10030475
• Product Code: MCW
• UDI-Device Identifier: 08714729889861
• UDI-Public: (01)08714729889861(17)270622(10)36587002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 112262-001
• Device Catalogue Number: 112262-001
• Device Lot Number: 0036587002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Patient Sex: Unknown