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

Model Number	H7493933515070
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidezilla was fractured.The 90% stenosed target lesion was located in the severely tortuous and severe calcified right coronary artery.A 7f guidezilla ii was selected for use.During the procedure, it was reported that the tip was fractured and damaged.The procedure was completed using another of the same device.No patient complications were reported, and patient is stable after the procedure.
Additional Manufacturer Narrative
E1 - (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone number: (b)(6) device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection found no damage or irregularity to the device.During microscopic inspection, the shaft was flattened from 0,5cm to 1cm from collar and it was found the tip of the device in good condition.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidezilla was fractured.The 90% stenosed target lesion was located in the severely tortuous and severe calcified right coronary artery.A 7f guidezilla ii was selected for use.During the procedure, it was reported that the tip was fractured and damaged.The procedure was completed using another of the same device.No patient complications were reported, and patient is stable after the procedure.

• 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: 21809717
• Report Number: 2124215-2025-20390
• Device Sequence Number: 15662077
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: (01)08714729939474(17)261007(10)35014089
• 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,Followup
• Report Date (Section B): 05/28/2025

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: 0035014089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 71 KG