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

Model Number	H7493892815200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.A percutaneous transluminal coronary angioplasty (ptca) was performed on a 70% stenosed target lesion located in the non-tortuous and non-calcified left anterior descending artery.A non-boston scientific (bsc) guide catheter was used to engage the vessel, and a 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, while advancing the balloon through the non-bsc guide catheter, the balloon catheter broke.The procedure was completed with a different device.There were no patient complications reported, and the patient was stable following the procedure.
Event or Problem Description
It was reported that shaft break occurred.A percutaneous transluminal coronary angioplasty (ptca) was performed on a 70% stenosed target lesion located in the non-tortuous and non-calcified left anterior descending artery.A non-boston scientific (bsc) guide catheter was used to engage the vessel, and a 2.00mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, while advancing the balloon through the non-bsc guide catheter, the balloon catheter broke.The procedure was completed with a different device.There were no patient complications reported, and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).E1.Initial reporter phone: (b)(6).Investigation results: media review: a photo was attached to the complaint record.The complaint device is visible and a break in the hypotube is evident and therefore the allegation can be confirmed.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of adverse event related to procedure.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.It is most likely procedural difficulties led to the reported break.These procedural factors would include interactions of the device with the non-boston scientific (bsc) guide catheter used during the procedure.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24636781
• Report Number: 2124215-2026-15155
• Device Sequence Number: 8689085
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)270221(10)33475972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: H7493892815200
• Device Catalogue Number: H7493892815200
• Device Lot Number: 0033475972
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 02/22/2024
• 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: 72 YR
• Patient Sex: Male