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

Model Number	80617
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the microcatheter was fractured.A renegade stc 18 catheter infusion was selected for use in transarterial chemoembolization (tace).During preparation, the outer package was unpacked.However, it was discovered that the tip of the microcatheter was fractured.The procedure was completed with a different device.There were no complications reported and the patient is stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was returned in the original shipping tube.The device was taken out of the shipping hoop and a portion of the device was completely detached from the rest of the shaft.The portion that was detached was approximately 8cm long from the hub.The shipping hoop was hydrated, and the remainder of the devices shaft was removed with no issues.No other damage was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.The complaint for a shaft break was confirmed.
Event or Problem Description
It was reported that the tip of the microcatheter was fractured.A renegade stc 18 catheter infusion was selected for use in transarterial chemoembolization (tace).During preparation, the outer package was unpacked.However, it was discovered that the tip of the microcatheter was fractured.The procedure was completed with a different device.There were no complications reported and the patient is stable.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10848156
• Report Number: 2134265-2020-15831
• Device Sequence Number: 3211297
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 07/27/2021
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0022569573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2018
• 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: 63 YR
• Patient Weight: 76