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

Model Number	H7493933515060
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis findings: the complaint device was received for product analysis.A visual inspection of the device revealed that there was a collar and shaft separation and there were numerous kinks and flats throughout the shaft of the device.No other issues were identified during the product analysis.Media review: media attached to the parent record shows packaging label.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.E1-initial reporter phone: (b)(6).E1-initial reporter address 1:.
Event or Problem Description
Reportable based on device analysis completed on 29apr2026.It was reported that the shaft broke during the pre-installation of the catheter and the rotational atherectomy device outside the patient.The target lesion was located in the left anterior descending branch.A 6f guidezilla was selected for use.During the pre-installation of the catheter and the rotational atherectomy device outside the patient, the catheter was split.The procedure was completed with another of the same device.There were no complications and patient had no abnormality after the procedure.However, device analysis revealed that the collar was detached.

• 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: 25257484
• Report Number: 2124215-2026-27757
• Device Sequence Number: 10535743
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270729(10)37076206
• 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): 05/22/2026

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: 0037076206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG