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

Model Number	29417
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was broke.The target lesion was located in the liver.A 18 renegade catheter-infusion was selected for use.During the procedure, it was noted that the catheter broke upon advancing.The device was pulled out completely from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was good post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The shipping hoop was hydrated, and the device was removed.The hub and shaft were visually inspected when returned.The renegade device showed multiple small bends and kinks.A fracture was noticed located 10.7cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for a fracture.
Event or Problem Description
It was reported that the catheter was broke.The target lesion was located in the liver.A 18 renegade catheter-infusion was selected for use.During the procedure, it was noted that the catheter broke upon advancing.The device was pulled out completely from the patient's body.The procedure was completed with another of same device.No complications were reported, and patient was good post procedure.

• Brand Name: RENEGADE
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15411627
• Report Number: 2124215-2022-33887
• Device Sequence Number: 6952460
• Product Code: DQO
• UDI-Device Identifier: 08714729375395
• UDI-Public: 08714729375395
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K020012
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 12/11/2024
• Device Model Number: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0028659023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: 65 YR
• Patient Sex: Male