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

Model Number	M001182480
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that difficulty tracking over the wire occurred.A 105/3.0/2.5/.021/20/straight renegade microcatheter was selected for use.During the procedure, it was noted that resistance was felt during tracking over the wire.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a shaft fracture located approximately 8.5cm from the strain relief.
Additional Manufacturer Narrative
Device analysis findings: upon receipt at our post market quality assurance laboratory, visual examination revealed a shaft fracture located approximately 8.5cm from the strain relief associated with a shaft stretch extending approximately 19cm from the strain relief.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which 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 review of the renegade 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 benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause linked to device but unable to trace more specifically.

• Brand Name: RENEGADE?
• 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: 25048860
• Report Number: 2124215-2026-23519
• Device Sequence Number: 16044714
• Product Code: DQO
• UDI-Device Identifier: 08714729375395
• UDI-Public: (01)08714729375395(17)280107(10)35576987
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K020012
• 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
• Report Date (Section B): 04/30/2026

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: M001182480
• Device Catalogue Number: M001182480
• Device Lot Number: 0035576987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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: 73 YR
• Patient Sex: Female