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

Model Number	80617
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that tip fractured upon withdrawal during unpacking.A renegade stc 18 was selected for use.Upon unpacking, the device was immersed in the saline solution, however the tip of the microcatheter was fractured when withdrawn.The procedure was completed with another of the same device.There were no patient complications reported and patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a slight stretching and a fracture of the shaft.The fracture was located at 9.2cm from the hub.The hub was completely separated from the shaft.The device was measured and the 150cm of the entire shaft was returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that tip fractured upon withdrawal during unpacking.A renegade stc 18 was selected for use.Upon unpacking, the device was immersed in the saline solution, however the tip of the microcatheter was fractured when withdrawn.The procedure was completed with another of the same device.There were no patient complications reported and patient was stable.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10587198
• Report Number: 2134265-2020-13278
• Device Sequence Number: 16458100
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 06/07/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0024066791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/23/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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: 46 YR