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

Model Number	112264-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel trauma occurred.Using the ipsilateral progressive approach, the first 1.6 mm jetstream catheter was placed to treat lower extremity arterial disease (lead) in the 90% stenosed, moderately tortuous and severely calcified target lesion located in the distal superficial femoral artery (sfa).Then, the second 2.1 mm jetstream xc catheter replaced the first 1.6 mm jetstream catheter.When increasing the size to the second 2.1 mm jetstream xc catheter, vessel perforation occurred, and an attempt was made to stop the bleeding using a non-bsc balloon.The balloon was exchanged for a non-bsc stent which was successful in stopping the bleeding.There were no further 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: 22469684
• Report Number: 2124215-2025-46074
• Device Sequence Number: 20856578
• Product Code: MCW
• UDI-Device Identifier: 08714729889892
• UDI-Public: (01)08714729889892(17)260824(10)34502472
• 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
• Report Date (Section B): 07/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2026
• Device Model Number: 112264-001
• Device Catalogue Number: 112264-001
• Device Lot Number: 0034502472
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 07/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown