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

Model Number	H74939335150610
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a kinked and fracture occurred.The target lesion was located in the left anterior descending branch.A 6f long guidezilla ii was used for treatment.The surface of the guidezilla was not smooth.During the procedure, the device got kinked and fractured before reaching the lesion.The device was removed with complications reported.There were no patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that at 6,5cm, 27,4cm and 39,2cm distal from the collar, the shaft of the device was kinked.
Event or Problem Description
It was reported that a kinked and fracture occurred.The target lesion was located in the left anterior descending branch.A 6f long guidezilla ii was used for treatment.The surface of the guidezilla was not smooth.During the procedure, the device got kinked and fractured before reaching the lesion.The device was removed with complications reported.There were no patient complications reported, and the patient was stable post procedure.It was further reported that the 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The device was pulled out directly from the patient without any additional intervention done.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 23345643
• Report Number: 2124215-2025-73317
• Device Sequence Number: 13124695
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)270219(10)35887786
• 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,Followup
• Report Date (Section B): 12/02/2025

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: 0035887786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 78 KG