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

Model Number	H7493892820250
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The coronary angiography of the patient showed 95% tubular stenosis of the right coronary artery.A 2.50mm x 20mm maverick balloon catheter was selected to pre-dilate the lesion.However, after opening its inner packaging, it was found out the shaft was broken and the front end of the balloon tip fractured.The device was replaced immediately, and the procedure was completed.The patient condition was stable post-procedure.
Event or Problem Description
It was reported that tip detachment occurred.The coronary angiography of the patient showed 95% tubular stenosis of the right coronary artery.A 2.50mm x 20mm maverick balloon catheter was selected to pre-dilate the lesion.However, after opening its inner packaging, it was found out the shaft was broken and the front end of the balloon tip fractured.The device was replaced immediately, and the procedure was completed.The patient condition was stable post-procedure.It was further reported that the physician pulled the device from the protective hoop and found the device fractured before connecting the pressure pump on the operating table.The balloon protector was removed and there was no midshaft debris left over at the pouch or protective hoop.
Additional Manufacturer Narrative
E.1.: initial reporter phone: (b)(6).Device evaluated by mfr.: fg maverick 2 mr, 2.50mm x 20mm balloon catheter was returned for analysis.A visual and tactile inspection of the hypotube shaft identified multiple kinks along the shaft.A break was identified on the midshaft, 37.5cm from the bumper tip.Further investigation noted that no midshaft break residue could be identified on the hypotube section of the device as expected.The broken end section of the midshaft also appeared to be cut rather than uneven as expected from a break.A detailed microscopic analysis of the balloon material showed no tears or pinholes in the balloon.The bumper tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands revealed no damage.

• 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: 22309680
• Report Number: 2124215-2025-40965
• Device Sequence Number: 18127050
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: (01)08714729370185(17)270521(10)34074623
• 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): 09/03/2025

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 Model Number: H7493892820250
• Device Catalogue Number: H7493892820250
• Device Lot Number: 0034074623
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: 75 YR
• Patient Sex: Female