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

Model Number	H74939335150610
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that at 74,4cm distal from the hub, the hypotube of the device was kinked.Additionally, the shaft was flattened from collar to 36,6cm and from 38,4cm to 39,9cm from collar including tip.Microscope inspection noticed a partial collar and shaft separation.
Event or Problem Description
Reportable based on device analysis completed on 30sep2025.It was reported that the device could not cross the lesion.The target lesion was located in the left anterior descending artery.A 6f long guidezilla ii was selected for percutaneous coronary intervention.During the procedure, it was noted that the device could not cross due to calcification.The procedure was completed with a different device.There were no complications reported, and the patient was good post procedure.However, device analysis revealed that a partial collar and shaft separation occurred.

• 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: 23372403
• Report Number: 2124215-2025-74547
• Device Sequence Number: 13292582
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)270411(10)36286035
• 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): 10/23/2025

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: 0036286035
• 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: 09/30/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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: 72 YR
• Patient Sex: Male