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

Model Number	H74939335150610
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	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the guidezilla ii 6f long guide extension catheter, batch 34016109.Visual and microscopic inspection were performed on the device.Visual inspection revealed numerous bends/kinks throughout the hypotube and shaft of the device and there were procedure residues in the guidezilla and the guidewire.Microscope inspection revealed numerous flats throughout the shaft of the device.There was a partial collar and shaft separation, and the tip was noticed damaged.
Event or Problem Description
Reportable based on device analysis completed on 25feb2025.It was reported that difficult to advance occurred.A 6f long guidezilla ii was selected for was selected for percutaneous coronary intervention (pci).During the procedure, it was noted that it was unable to get promus elite stent through the guidezilla guide extension catheter.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that a partial collar and shaft separation was 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21618784
• Report Number: 2124215-2025-13678
• Device Sequence Number: 17849406
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/17/2025

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: 05/13/2026
• Device Model Number: H74939335150610
• Device Catalogue Number: H74939335150610
• Device Lot Number: 0034016109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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