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

Model Number	H7493933515060
Medical Device Problem Code	Break (1069)
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).Investigation results: device analysis findings: device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device revealed that there was a collar weld plate separation.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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of unintended use error caused or contributed to event following a review of the returned device, reported event details, available information, and product record review.Regarding the observed collar weld plate separation, that can occur during unpacking from unintended inappropriate use during interaction between the user and device.Based on analysis and the reported information, the reported event likely occurred as a result of factors encountered during handling.
Event or Problem Description
Reportable based on device analysis completed on 10mar2026.It was reported that a shaft break occurred.A 6f guidezilla ii catheter-guide extension was selected for an angiography for treatment of distal segment of right coronary artery.During unpacking, it was found the guidezilla fractured.There were no patient complications, and the patient was stable post procedure.However, device analysis revealed a collar weld plate 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: 24767269
• Report Number: 2124215-2026-18182
• Device Sequence Number: 10267926
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270225(10)35931908
• 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): 04/02/2026

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: H7493933515060
• Device Catalogue Number: H7493933515060
• Device Lot Number: 0035931908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG