MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE? STC 18; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	M001181310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility number (b)(4).
Event or Problem Description
It was reported that tip rupture occurred.The target lesion was located in the iliac artery.A renegade? stc 18 catheter infusion was selected for use.During the procedure, the tip was ruptured.The procedure was completed using with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility number - (b)(6).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 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 risk review: a risk review performed for the 18 otw catheters periph device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was unable to exclude device problem.
Event or Problem Description
It was reported that tip rupture occurred.The target lesion was located in the iliac artery.A renegade? stc 18 catheter infusion was selected for use.During the procedure, the tip was ruptured.The procedure was completed using with a different device.There were no patient complications as a result of this event.It was further reported that the device removed by simply pulled out.

• Brand Name: RENEGADE? STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24434576
• Report Number: 2124215-2026-10249
• Device Sequence Number: 10297368
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: (01)08714729444442(17)281006(10)37645948
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023681
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: M001181310
• Device Catalogue Number: M001181310
• Device Lot Number: 0037645948
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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 Age: 58 YR
• Patient Sex: Male