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	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter fracture occurred.A 6f long guidezilla ii was selected for percutaneous coronary intervention.During the procedure, it was noted that the catheter fracture.The procedure was completed with another of same device.There were no patient complications, and the condition of the patient post procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Investigation results: media review: the media provided by the site shows a collar weld plate separation.Device analysis findings: inspection revealed that there was a collar weld plate separation.Additionally, the shaft was flattened from 22,2cm to 25cm from collar and was kinked at 38,2cm and 39cm from collar.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 adverse event related to procedure following a review of the returned device, reported event details, available information, and product record review.The reported event likely occurred as a result of factors encountered during the procedure of which can include handling of the device.Also, since the dhr review confirmed that the device met all manufacturing specifications, it is probably that the forces resulting to the collar weld separation, the shaft flattened and shaft kinks likely occurred during the procedure.
Event or Problem Description
It was reported that a catheter fracture occurred.A 6f long guidezilla ii was selected for percutaneous coronary intervention.During the procedure, it was noted that a catheter fracture occurred.The procedure was completed with another of same device.There were no patient complications, and the condition of the patient post procedure was stable.

• 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: 24349321
• Report Number: 2124215-2026-08604
• Device Sequence Number: 9986988
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 0036630916
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2026
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 09/03/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/01/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 143 LB