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

Model Number	H74939335150610
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 09may2025.It was reported that the device could not cross the lesion due to angulation.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified proximal left circumflex artery.A 6f guidezilla ii catheter-guide extension was selected for use.During the procedure, the device could not cross the lesion due to angulation.The procedure was completed with another of the same device.No complications reported and patient was in good condition post procedure.However, device analysis revealed a partial collar and shaft detachment.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device found a numerous kinks throughout the shaft and the hypotube of the device.A microscopic inspection of the device revealed that there was partial collar and shaft separation.No other issues were identified during the product analysis.

• 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: 22136604
• Report Number: 2124215-2025-34327
• Device Sequence Number: 20668372
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: 08714729939467
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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 Model Number: H74939335150610
• Device Catalogue Number: H74939335150610
• Device Lot Number: 0035457850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female