MAUDE Adverse Event Report: GUIDEZILLA; CATHETER, PERCUTANEOUS

Model Number	1867
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The shaft, collar, and tip were microscopically and visually examined.There was blood present inside the device.Inspection of the device revealed that there was a partial shaft separation at the collar.The polytetrafluoroethylene (ptfe) was still attached and not separated inside the collar and shaft.There was damage to the end of the shaft separation and a slight kink just distal of the separation.There was only a slight kink present during analysis; however, it was most likely that the shaft got severely kinked at the collar/shaft transition, resulting in the partial separation of the shaft and the difficulty advancing.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the catheter was kinked.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the catheter was kinked and could not be delivered into the lesion.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.However, device analysis revealed a shaft separation.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• MDR Report Key: 12751828
• Report Number: 2134265-2021-13496
• Device Sequence Number: 19195985
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123765
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 10/29/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026272976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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: 60 YR
• Patient Weight: 59