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

Model Number 80617

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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unpacking, the device was immersed in the saline solution, however the tip of the microcatheter was fractured when withdrawn.The procedure was completed with another of the same device.There were no patient complications reported and patient was stable.

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 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unpacking, the device was immersed in the saline solution, however the tip of the microcatheter was fractured when withdrawn.The procedure was completed with another of the same device.There were no patient complications reported and patient was stable.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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10587198
• MDR Text Key: 208557933
• Report Number: 2134265-2020-13278
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729444503
• UDI-Public: 08714729444503
• Combination Product (y/n): N
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR