MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE? HI-FLO? KIT; CATHETER, CONTINUOUS FLUSH

Model Number	M001183020
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire separation occurred.The patient underwent a uterine artery embolization procedure for treatment of adenomyosis/hysteromyoma.The 70% stenosed target lesion was located in a mildly tortuous and mildly calcified uterine artery.A 135/10 renegade hi-flo kit microcatheter was used for a super-selective uterine artery procedure.After flushing with normal saline, the catheter could not be withdrawn smoothly.During withdrawal, the guidewire fractured and separated within the catheter.The distal tip of the guidewire could not be removed, and the catheter could no longer be used.The procedure was completed with another of same device.The patient was stable after the procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.

• Brand Name: RENEGADE? HI-FLO? KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 25234086
• Report Number: 2124215-2026-27276
• Device Sequence Number: 16041656
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: (01)08714729280774(17)270113(10)35619682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• 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): 06/12/2026

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: M001183020
• Device Catalogue Number: M001183020
• Device Lot Number: 0035619682
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: 65 YR
• Patient Sex: Unknown
• Patient Weight: 74 KG