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

Model Number	80617
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Advance (2524)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was clamping of the proximal left bronchial artery and arterial occlusion.The target lesion was located in the bronchial artery.A 150/20 renegade stc 18 catheter infusion was selected for use.During the procedure, a super selection was performed with a microguide wire and a microcatheter.The microguide enter in the left bronchial artery however, the angle of the vessel was large and the microcatheter was too stiff to follow up.Several attempts were made, but a formation of clamping in the proximal left bronchial artery and arterial occlusion occurred.The device was simply pulled out from the patient's body and the procedure was completed.No further complications were reported and patient was fine post procedure.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14476514
• Report Number: 2134265-2022-05292
• Device Sequence Number: 14786284
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0028416816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male