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

Model Number 1871

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a guidezilla ii guide extension catheter.Analysis of the tip, distal shaft, collar and hypotube included microscopic and visually inspection.Inspection revealed a kink in the distal shaft located 11.8 cm form the tip of the device, and collar damage.Inspection of the rest of the device found no other damage or defect.The devices used in the procedure were not returned for analysis, so the guidezilla was functionally tested with a 6f guide catheter, supplied by the lab.The guidezilla loaded into the hub of the guide catheter and advanced through the guide catheter, past the kink and collar damage and out the tip.

Event Description

Reportable based on device analysis completed on 25mar2020.It was reported that the guidezilla ii cannot cross the guide catheter, got stuck and damaged upon removal.A 6f guidezilla ii was selected for use.During procedure, the guidezilla ii wasn't advanced on a 6fr guide catheter and eventually got stuck and damaged during removal.However, it was further reported that was a kink mid-shaft of the catheter and helical collar was deformed.The device was removed and replaced with another of the same device to complete the procedure.No patient complications were reported.However, device analysis revealed collar damage.

• Brand Name: GUIDEZILLA II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9912539
• MDR Text Key: 186096756
• Report Number: 2134265-2020-04266
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: 08714729939450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Model Number: 1871
• Device Catalogue Number: 1871
• Device Lot Number: 0024586256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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