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

Model Number	H7493933515070
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the complaint device was received for product analysis.Inspection revealed that the shaft was flattened from 12,2cm to 13,2cm from collar.It was found the collar weld kinked and a partial collar and shaft separation.Additionally, it was noticed the tip in good condition.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 29sep2025.It was reported that the device could nor cross the lesion and tip damaged occurred.The 20mm x 3.5mm in diameter, 90% stenosed target was located in the mildly tortuous and mildly calcified right coronary artery (rca).A guidezilla ii catheter-guide extension was selected for use.During the procedure, it was noted that the device could not cross the lesion when it entered.After withdrawal, it was found that it had kink mark at the tip of the guidezilla.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.However, device analysis revealed a partial collar and shaft separation.

• 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: 23345920
• Report Number: 2124215-2025-74609
• Device Sequence Number: 13124578
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: (01)08714729939474(17)260614(10)34241926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/21/2025

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: 06/14/2026
• Device Model Number: H7493933515070
• Device Catalogue Number: H7493933515070
• Device Lot Number: 0034241926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 74 KG