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

Model Number	80617
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft was broken.A renegade stc 18 catheter was selected for use.During preparation, when taking out the device from the carrier, there was too much friction felt between the catheter and carrier.The device was successfully taken out, however the proximal shaft was broken.The device had not been advanced to the patient's artery.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the shaft was broken.A renegade stc 18 catheter was selected for use.During the preparation, when taking out the device from the carrier, there was too much friction felt between the catheter and carrier.The device was successfully taken out, however the proximal shaft was broken.The device had not been advanced to the patient's artery.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the catheter surface and carrier tube are flushed prior to removal from carrier hoop.The patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade hi flo showed damage in the form of a separation in the hub.The inner liner was separated also.The separation looked consistent with a bending and tensile force breaking which could be caused by insufficient flushing of saline before removing the device from the carrier.Because of the damage to the catheter no other functional testing was done.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was consistent with the reported information of a separation or break.

• Brand Name: RENEGADE STC 18
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11807240
• Report Number: 2134265-2021-05593
• Device Sequence Number: 3634877
• Product Code: DQO
• UDI-Device Identifier: 08714729444442
• UDI-Public: 08714729444442
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 06/21/2021

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: 06/08/2022
• Device Model Number: 80617
• Device Catalogue Number: 80617
• Device Lot Number: 0024074708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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