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

Model Number	H74939335150610
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the collar was cracked.The patient was presented with a coronary atherosclerotic heart disease and unstable angina and underwent a coronary stent implantation and percutaneous coronary balloon dilation angioplasty procedure.The target lesion was 80% stenosed, proximally diffused and calcified.99% subtotal occlusion was also noted in the mid right coronary artery.A 6f long guidezilla ii catheter guide extension was selected for use.During the procedure, it was noted that the collar of the device had a crack at the connection, and a quality issue was suspected.The device was removed normally, and the procedure was completed with another of the same device.There were no patient complications, and the patient remained stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer: the complaint device was received for product analysis.A visual and microscope inspection found no damage or irregularity to the device.
Event or Problem Description
It was reported that the collar was cracked.The patient was presented with a coronary atherosclerotic heart disease and unstable angina and underwent a coronary stent implantation and percutaneous coronary balloon dilation angioplasty procedure.The target lesion was 80% stenosed, proximally diffused and calcified.99% subtotal occlusion was also noted in the mid right coronary artery.A 6f long guidezilla ii catheter guide extension was selected for use.During the procedure, it was noted that the collar of the device had a crack at the connection, and a quality issue was suspected.The device was removed normally, and the procedure was completed with another of the same device.There were no patient complications, and the patient remained stable post procedure.

• 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: 23467314
• Report Number: 2124215-2025-78496
• Device Sequence Number: 15940131
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)261210(10)35457853
• 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): 12/23/2025

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: 0035457853
• 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: 10/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 55 KG