MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE STC18 MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number GTIN 150 X 30 M00118140

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

Full dose of y-90 treatment was not administered as the product was stuck in the catheter.

• Brand Name: RENEGADE STC18 MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12294340
• MDR Text Key: 265795947
• Report Number: MW5103094
• Device Sequence Number: 1
• Product Code: KRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/07/2024
• Device Model Number: GTIN 150 X 30 M00118140
• Device Lot Number: 26937614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR