MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS

Model Number	1867
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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.Blood was present inside the shaft.Inspection of the device revealed that there was a shaft separation at the collar.There was damage to the end of the shaft separation and the collar was damaged.The ptfe was pulled out of the collar and attached to the distal shaft.The entire shaft was flattened after the shaft separation to the markerband and tip.Product analysis confirmed the reported event, as the shaft was separated from the collar and the shaft/markerband and tip were flattened.
Event or Problem Description
Reportable based on device analysis completed on 06oct2021.It was reported that difficulty advancing through catheter occurred.The 80% stenosed target lesion was located in the right coronary artery.A guidezilla guide extension catheter was selected for use.During the procedure, it was noted that the device could not cross the wire lumen and there was a bent on the tip of the guidezilla.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed that the shaft was separated from the collar.

• Brand Name: GUIDEZILLA
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12661458
• Report Number: 2134265-2021-12977
• Device Sequence Number: 13754946
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 09/23/2022
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0026064690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 51