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

Model Number 80617

Device Problems Mechanical Problem (1384); Failure to Advance (2524)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/20/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 292477275
• Report Number: 2134265-2022-05292
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444503
• UDI-Public: 08714729444503
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male