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	Unintended Radiation Exposure (4565)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred.A 7f guidezilla ii was selected for use.During procedure, it was noted that the guidezilla ii 7f did not navigate properly through the non-boston scientific (non-bsc) guide catheter, even after removing the y connector.After removal from the patient, the guidezilla was tested again but continued to fail to pass through the catheter lumen.Visual inspection did not detect any damage to either the non-bsc guide catheter or the guidezilla.The procedure was completed with another of the same device.The device failure resulted in a delay in the procedure, which led to increased radiation and contrast consumption.No patient complications were reported.However, device analysis revealed partial separations.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr.: the device was returned for analysis.A visual examination revealed hypotube kinks at 7.8cm and 109 cm distal from the hub and shaft kinks at 5.9cm and 22cm from collar.Microscopic examination revealed shaft flats at 4.1cm and from 7cm to 10cm from the collar.A partial collar and shaft separation with a small twisting were noted.

• Brand Name: GUIDEZILLA II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21369247
• Report Number: 2124215-2025-07834
• Device Sequence Number: 8435008
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 07/26/2025
• Device Model Number: 1873
• Device Catalogue Number: 1873
• Device Lot Number: 0032096405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC LAUNCHER EBU 7F.
• Patient Sex: Unknown