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

Model Number	H74939335150610
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that additional intervention was required.A 6f guidezilla ii was selected for use in the left coronary artery.During the procedure, it was noted that the catheter tip could not cross the left coronary lesion.The device was removed with the help of a balloon.The procedure was completed with another of the same device.There were no patient complications, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that additional intervention was required.A 6f guidezilla ii was selected for use in the left coronary artery.During the procedure, it was noted that the catheter tip could not cross the left coronary lesion.The device was removed with the help of a balloon.The procedure was completed with another of the same device.There were no patient complications, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone number: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone number: (b)(6).With all the available information, boston scientific concludes: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 adverse event related to procedure following a review of the reported event details, available information, and product record review.In this case, it was not possible to confirm the presence or absence of the reported issue with the device since it was not returned for analysis.However, it is likely that the issue could be related to an excessive force applied to the device during procedure, as well as operational or procedural factors such as handling/technique of the user causing the reported event.Regarding the reported additional device required, according to the event description, the event may have been caused by a possible device malfunction that resulted in the reported issue.

• 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(612)875-7234
• MDR Report Key: 50147007
• Report Number: 2124215-2026-41989
• Device Sequence Number: 10603230
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H74939335150610
• Device Catalogue Number: H74939335150610
• Device Lot Number: 0037035289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 07/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 158 LB