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

Model Number	80617
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade was hydrated, and a guidewire was inserted.Slight resistance was felt 51 cm from the hub, but the guidewire passed through to the end.A small piece of the inner liner was dislodged and came out the end with the guidewire.Two kinks were noted on the catheter 1.5 cm and 1.1 cm from the distal end.Inspection of the remainder of the device revealed no damage.Device analysis determined the condition of the returned device was not consistent with the reported information of a difficult to insert or jammed.Ftir analysis found the material that came out during testing is spectrally similar to fluorocarbon fiber, which is commonly associated to gauze or soaker pads, which likely was present on the guidewire prior to introduction into the renegade.
Event or Problem Description
Reportable based on device analysis completed on 30jun2021.It was reported that the guidewire could not go forward.The target lesion was located in the splenic artery.A renegade stc 18 catheter infusion was selected for use.During the procedure, after reaching the main splenic artery, the renegade microcatheter was flushed and taken out.A 0.014 non boston scientific guidewire was then inserted along with the catheter; however after reaching the middle of the microcatheter, the guidewire could not go forward.Repeated attempts all failed and replacement of a guidewire still could not work.The microcatheter was not bent or broken after checking and a new 2.4f microcatheter was unpacked and the same guidewire could cross successfully.Lastly, the coil was deployed successfully with the new microcatheter for embolization.The procedure was successfully completed and the patient was fine post procedure.However, device analysis revealed that a small piece of the inner liner was dislodged and came out the end with the guidewire.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12197084
• Report Number: 2134265-2021-08921
• Device Sequence Number: 3590619
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: 03/25/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023692055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2019
• 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: 62 YR
• Patient Weight: 65