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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device fracture occurred.The target lesion was located in a coronary artery.A 6f guidezilla catheter guide extension was selected for use.During the procedure, the tip was fractured.The procedure was successfully completed using a new extension catheter.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.H6 - device codes: corrected.(b)(6).
Event or Problem Description
It was reported that device fracture occurred.The target lesion was located in a coronary artery.A 6f guidezilla catheter guide extension was selected for use.During the procedure, the tip was fractured.The procedure was successfully completed using a new extension catheter.No complications were reported, and patient was stable post procedure.It was further reported that the device was folded in half but did not break.It was completely removed by simply pulling it from the body of the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection found no damage or irregularity to the device.A microscopic inspection revealed that at 39,7cm distal from the collar, the shaft of the device was kinked near of tip.No other issues were identified during the product analysis.E1 - initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device fracture occurred.The target lesion was located in a coronary artery.A 6f guidezilla catheter guide extension was selected for use.During the procedure, the tip was fractured.The procedure was successfully completed using a new extension catheter.No complications were reported, and patient was stable post procedure.It was further reported that the device was folded in half but did not break.It was completely removed by simply pulling it from the body of the patient.

• 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: 22603520
• Report Number: 2124215-2025-48920
• Device Sequence Number: 13152751
• Product Code: DQY
• UDI-Device Identifier: 08714729939467
• UDI-Public: (01)08714729939467(17)261009(10)35027152
• 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,Followup
• Report Date (Section B): 12/04/2025

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: 0035027152
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 11/12/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/05/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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: 46 KG