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

Model Number	H7493933515070
Medical Device Problem Codes	Nonstandard Device (1420); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
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 there was a partial collar and shaft separation.The shaft was flattened at 11.2cm and 12.2cm from collar.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that crossing difficulties were encountered.A percutaneous coronary intervention (pci) was performed on a patient with chest pain.A 7f guidezilla ii guide extension catheter was selected for use.During the procedure, there was a lot of resistance when advancing the 1.50mm rotapro through the guidezilla into the patient.After several failed attempts, the system was removed.The rotapro was pre-loaded within the guidezilla and dyna-glided before further introduction of the guidezilla.The procedure was completed using this device.There were no patient complications.However, device analysis revealed a partial collar 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: 23918451
• Report Number: 2124215-2025-93595
• Device Sequence Number: 18429856
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: (01)08714729939474(17)270729(10)37076504
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: H7493933515070
• Device Catalogue Number: H7493933515070
• Device Lot Number: 0037076504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 12/29/2025
• 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 Sex: Unknown