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

Model Number	H7493933515060
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results: media review: media provided by the customer only showed the packaging label.Device analysis findings: the complaint device was received for product analysis.A visual inspection revealed that there was a collar weld 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.Investigation conclusion: this investigation has been assigned an investigation conclusion code of no problem detected as the reported catheter kink could not be confirmed.The collar weld separation found on analysis can occur during unpacking due to interaction between the user and the device, therefore unintended use error caused or contributed to event is the assigned cause for the encountered collar weld separation.
Event or Problem Description
Reportable based on device analysis completed on 21apr2026.It was reported that the device kinked.A 6f guidezilla ii was selected for use.The guidezilla was found kinked after unpacking.The procedure was completed with another of same device.There were no patient complications, and the patient was stable post procedure.However, device analysis revealed a collar weld 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: 25160544
• Report Number: 2124215-2026-25803
• Device Sequence Number: 10694531
• Product Code: DQY
• UDI-Device Identifier: 08714729939450
• UDI-Public: (01)08714729939450(17)270724(10)37051868
• 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): 05/13/2026

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: 0037051868
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 Sex: Unknown