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

Model Number	80617
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a renegade stc-18 microcatheter.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed inner shaft damage (inner shaft delamination) that partially blocked the inside of the shaft 26.2cm from the strain relief.A guide wire was inserted into the shaft of the device, and while the wire advanced fully, there was some resistance while advancing.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
Reportable based on device analysis completed on 25jun2020.It was reported that the device could not cross lesion.The target lesion was located in the 60% tortuous splenic artery.A renegade stc 18 catheter was selected for use in a splenic aneurysm embolization.During preparation, the stc18 micro catheter was flushed with saline.The catheter was advanced into the patient's body through the micro guidewire.Subsequently, the device could not cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed an inner shaft delamination.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10257502
• Report Number: 2134265-2020-09174
• Device Sequence Number: 11634196
• Product Code: DQO
• UDI-Device Identifier: 08714729444503
• UDI-Public: 08714729444503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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 Expiration Date: 04/20/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023825794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR