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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GUIDEZILLA II CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameGUIDEZILLA II
Type of DeviceCATHETER, 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 Key9912539
MDR Text Key186096756
Report Number2134265-2020-04266
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1871
Device Catalogue Number1871
Device LOT Number0024586256
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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