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

Model Number	H7493933515070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred.A patient experienced a renal artery dissection, potentially associated with the use of the 7 fr guidezilla ii guide catheter.The physician confirmed through live fluoroscopy imaging that a non-boston scientific catheter was not introduced into the inferior branch of the right renal artery.Only the guidewire and guidezilla ii catheter were placed in the inferior branch, where the dissection occurred.The physician suggested that the likely cause of the dissection was the force applied by the 7 fr guidezilla ii guide catheter as it navigated the area where the inferior branch curved upward.Following an unsuccessful angioplasty with a 2.5 x 15mm emerge balloon catheter to treat the dissection, the dissection was treated by placing two boston scientific synergy xd drug-eluting stents.The first stent, a 3 x 8mm synergy xd des, was placed in the inferior branch of the right renal artery, while the second stent, a 4 x 12mm synergy xd des, was positioned from the proximal portion of the inferior branch into the main branch of the right renal artery.The procedure was completed, and the patients condition remained stable.They were subsequently transferred to the recovery area and discharged on the same day.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21471881
• Report Number: 2124215-2025-10117
• Device Sequence Number: 8658496
• Product Code: DQY
• UDI-Device Identifier: 08714729939474
• UDI-Public: 08714729939474
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H7493933515070
• Device Catalogue Number: H7493933515070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown