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

Model Number	112264-001
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that aspiration stopped working.A 2.1mm jetstream? xc catheter was selected for endovascular therapy of the superficial femoral artery.The lesion had 100 percent stenosis with severe calcification and moderately tortuous.After a few passes of treatment with blades up and down, the roller pump was rotating but there was no suction from the effluent tube.The procedure was completed successfully using this device without sequelae.
Event or Problem Description
It was reported that aspiration stopped working.A 2.1mm jetstream? xc catheter was selected for endovascular therapy of the superficial femoral artery.The lesion had 100 percent stenosis with severe calcification and moderately tortuous.After a few passes of treatment with blades up and down, the roller pump was rotating but there was no suction from the effluent tube.The procedure was completed successfully using this device without sequelae.
Additional Manufacturer Narrative
Device analysis: the device returned to boston scientific consisted of a jetstream atherectomy catheter.The device was visually and microscopically examined for any damage.Visual and microscopic examination revealed no damages.Functional testing was performed by inserting the device into a jetstream console.The device was able to prime and run as intended.Inspection of the remainder of the device revealed no damage or irregularities.Product analysis could not confirm the failure to evacuate.

• 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: 22739843
• Report Number: 2124215-2025-55107
• Device Sequence Number: 7198385
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)260314(10)33408647
• 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): 09/15/2025

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 Expiration Date: 03/14/2026
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0033408647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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