MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493892815270
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the patient status and the device status, but further information was unable to be obtained.
Event or Problem Description
It was reported that removal difficulty occurred.The 60% stenosed target lesion was located in the severely calcified aorta non-coronary cusp.A 2.75mm x 15mm maverick 2 balloon catheter was advanced for dilation.During the transcatheter aortic valve implantation (tavi) procedure, while accessing the valve, the safari2 guidewire became stuck within the balloon, preventing its removal.Given the patient's safety as the primary concern, both the wire and balloon were removed, and a new guidewire and balloon were used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulty occurred.The 60% stenosed target lesion was located in the severely calcified aorta non-coronary cusp.A 2.75 mm x 15 mm maverick 2 balloon catheter was advanced for dilation.During the transcatheter aortic valve implantation (tavi) procedure, while accessing the valve, the safari2 guidewire became stuck within the balloon, preventing its removal.Given the patients safety as the primary concern, both the wire and balloon were removed, and a new guidewire and balloon were used to complete the procedure.No patient complications were reported.It was further reported that the catheter was stuck with the safari wire was a non-boston scientific device.

• Brand Name: MAVERICK?
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22169510
• Report Number: 2124215-2025-36342
• Device Sequence Number: 9255391
• Product Code: LOX
• UDI-Device Identifier: 08714729370093
• UDI-Public: (01)08714729370093(17)081202(10)8239621
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P860019
• 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,Followup
• Report Date (Section B): 07/03/2025

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 Expiration Date: 12/02/2008
• Device Model Number: H7493892815270
• Device Catalogue Number: H7493892815270
• Device Lot Number: 0008239621
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 12/04/2005
• 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