MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Maverick?; catheters, transluminal coronary angioplasty, percutaneous

Model Number	H7493892815150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient presented with 95% stenosis of the left anterior descending artery (lad) and 90% stenosis of the right coronary artery (rca) with high calcium and tortuosity of the vessel.After the bed was prepared with a 1.50 x 15 mm maverick 2 balloon a non-boston scientific (non-bsc) stent was deployed and post dilated successfully.The proximal rca was then pre-dilated with a 2.00 x 12 mm maverick 2 balloon and another non-bsc stent was successfully deployed and post-dilated.After deployment of the second stent in the rca, a non-bsc drug coated balloon was used at the proximal end.After completion of the procedure, the patient was stable and sent to the coronary care unit for post-procedural monitoring.During the night, the patient developed hypotension and went into cardiac arrest.Cardiopulmonary resuscitation was immediately started and continued.Once the pressure got done and the patient did not come back, they were declared expired.An autopsy was not performed.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).

• 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 ; +1(612)875-7234
• MDR Report Key: 50800969
• Report Number: 2124215-2026-49609
• Device Sequence Number: 10548902
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)280227(10)35949523
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0035949523
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 02/27/2025
• 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: Death
• Patient Sex: Unknown