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

Model Number	H74939335150610
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a tip fracture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 6f guidezilla ii was selected for percutaneous coronary intervention.During the procedure, it was noted that the tip of the device was fractured.The device was simply removed from the patient.The procedure was completed with another of the same device.There were no complications reported, and the patient is stable post procedure.
Event or Problem Description
It was reported that a tip fracture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified artery.A 6f guidezilla ii was selected for percutaneous coronary intervention.During the procedure, it was noted that the tip of the device was fractured.The device was simply removed from the patient.The procedure was completed with another of the same device.There were no complications reported, and the patient is stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.The shaft was flattened from 38,8cm to 39,5cm from collar including tip.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of device problem excluded following a review of the returned device, reported event details, available information, and product record review.In this case, the device performed as intended during the analysis, and no damage was found that could have contributed to the reported allegation.Regarding the observed shaft flattened including tip, this can occur during the procedure due to the advancement maneuvers.Based on analysis and the reported information, the reported event likely occurred as a result of factors encountered during the procedure of which can include handling of the device.Therefore, adverse event related to procedure is the assigned cause for the encountered shaft flattened including tip.

• 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: 23766435
• Report Number: 2124215-2025-90064
• Device Sequence Number: 21268095
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)261217(10)35506112
• 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): 03/25/2026

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: 0035506112
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG