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

Model Number	M001181310
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that procedure was cancelled.The target lesion was located in a vessel of below the knee.A renegade stc 18 was selected for use in the embolization.During the procedure, the coil was advance inside the catheter, however, resistance was noted, and the coil could not be deployed.Consequently, the access was lost.The coil and the microcatheter were removed.The microcatheter was flushed, and it was noted that there is a leakage in the catheter.Multiple approaches were tried but failed.The procedure was not completed due to this event.No complications were reported.It was further reported that the patient was under general anesthesia when the issue occurred.The coil used was a non-boston scientific device and was able to be taken out before being deployed.
Event or Problem Description
It was reported that procedure was cancelled.The target lesion was located in a vessel of below the knee.A renegade stc 18 was selected for use in the embolization.During the procedure, the coil was advance inside the catheter, however, resistance was noted, and the coil could not be deployed.Consequently, the access was lost.The coil and the microcatheter were removed.The microcatheter was flushed, and it was noted that there is a leakage in the catheter.Multiple approaches were tried but failed.The procedure was not completed due to this event.No complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20966156
• Report Number: 2124215-2024-77576
• Device Sequence Number: 15544169
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Model Number: M001181310
• Device Catalogue Number: M001181310
• Device Lot Number: 0033205001
• 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: 12/01/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/29/2025
• Date Device Manufactured: 01/13/2024
• 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 Age: 38 YR
• Patient Sex: Female