MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Guidezilla? II; catheter, percutaneous

Model Number	H7493933515060
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a detachment occurred.The patient presented with st elevation myocardial infarction.The 100% stenosed target lesion was located in the right coronary artery.A guidezilla ii was selected for use.The guidezilla was loaded onto the guidewire and when it was entering the guide catheter, it was noted that the guidezilla had separated at the collar.The device was removed in one piece using the normal method.The same event happened with a second guidezilla.The procedure was completed using a second guidewire for support.There were no patient complications, and the patient fully recovered after the procedure.
Event or Problem Description
It was reported that a detachment occurred.The patient presented with st elevation myocardial infarction.The 100% stenosed target lesion was located in the right coronary artery.A guidezilla ii was selected for use.The guidezilla was loaded onto the guidewire and when it was entering the guide catheter, it was noted that the guidezilla had separated at the collar.The device was removed in one piece using the normal method.The same event happened with a second guidezilla.The procedure was completed using a second guidewire for support.There were no patient complications, and the patient fully recovered after the procedure.
Additional Manufacturer Narrative
Investigation results: media review: media attached to the parent record shows a collar weld separation.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 the conclusion code of unintended use error caused or contributed to event following a review of the reported event details, available information, and product record review.Based on the reported information, the reported event likely occurred as a result of factors encountered during handling.The event can occur during procedure, outside the patient from unintended inappropriate use during interaction between the user and device.

• 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 ; +1(763)494-1632
• MDR Report Key: 25110665
• Report Number: 2124215-2026-24724
• Device Sequence Number: 10280154
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)280112(10)38318833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2026

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: 0038318833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/22/2026; 07/22/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/11/2026; 08/11/2026
• Date Device Manufactured: 01/12/2026
• 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 Sex: Unknown