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

Model Number	80617
Medical Device Problem Codes	Collapse (1099); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
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 showed damage in the form of shaft damage from approx.2 mm to 3.6 cm from the tip.An obstruction was determined to be approx.2 cm from the tip and was removed with a guide wire.Ftir testing showed the obstruction to be similar in composition to the fluorocarbon fiber used in the inner tube.Further analysis revealed damage in the form of kinks 131.5, 141 cm and 142 cm from the hub.Inspection of the remainder of the device revealed no damage or irregularities.
Event or Problem Description
Based on device analysis completed on 05apr2021.It was reported that distal part of the catheter was bulging.A 150/30 renegade stc 18 was selected for use.Upon preparation, it was noted that the distal part of the microcatheter was obstructed.Subsequently, there was a bulging in the distal part approximately 3-4cm.No patent complications were reported.However, device analysis revealed an obstruction of foreign material.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11744885
• Report Number: 2134265-2021-05234
• Device Sequence Number: 14532779
• Product Code: DQO
• UDI-Device Identifier: 08714729444510
• UDI-Public: 08714729444510
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2021

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: 01/01/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0023281281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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