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

Model Number	1873
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned.The shaft, collar, and tip were microscopically and visually examined.Inspection of the device revealed that the collar was kinked and partially detached as it was lifted from the shaft material.There were numerous kinks also throughout the shaft of the device.The shaft and tip were flattened for 1cm from the end of the tip.The damage to the device is consistent to damage that can be caused due to handling of the device during preparation or while inserting into another device into the guidezilla device.The balloon catheter used in the procedure was not returned for analysis, so a test balloon catheter was used for functional testing.The tip was inserted into the collar, but resistance was met at the kinked and damaged collar.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 06jan2023.It was reported that another device couldn't advance through the guidezilla.A 7f guidezilla ii guide extension catheter was selected for use.During procedure, there was difficulty inserting another device to the guidezilla.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that collar was partially detached as it was lifted from the shaft material.

• Brand Name: GUIDEZILLA II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16158384
• Report Number: 2124215-2023-01156
• Device Sequence Number: 20572621
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 04/14/2024
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0029404202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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 Sex: Unknown