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

Model Number	H7493933515070
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issues occurred.The target lesion was located at the bifurcation of the distal right coronary artery.A 7f guidezilla was selected for use.A synergy stent was advanced, and a 2.50 x 20mm balloon was advanced for protection.Significant difficulty was encountered while using the guidezila, resulting in balloon entrapment and fracture.Upon removal of the whole system, the stent became damaged, and the guidezilla was retrieved completely deformed.The procedure was completed with an alternative device.There were no patient complications.

• 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: 23696708
• Report Number: 2124215-2025-87540
• Device Sequence Number: 16046123
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: (01)08714729939474(17)270402(10)36208020
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/02/2025

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: H7493933515070
• Device Catalogue Number: H7493933515070
• Device Lot Number: 0036208020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT-SYNERGY
• Patient Sex: Unknown