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

Model Number	H7493892815250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% target lesion was located in the moderate to severely tortuous and mildly calcified left anterior descending artery.The first 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilation.However, at 8 - 12 atmospheres, the balloon ruptured.Then, second 2.50mm x 15mm maverick 2 balloon catheter was used to pre-dilate the left anterior descending artery lesion at 8 - 12 atmospheres, but balloon rupture was observed.The non-bsc guidewire from the third diagonal branch was exchanged to the second diagonal branch, and the 2.5mm x 15mm maverick balloon was used to pre-dilate the second diagonal branch lesion at 8 - 12 atmospheres.An attempt to advance the 2.5mm x 10mm wolverine cutting balloon to the lesion in the anterior descending artery was unsuccessful.The diagonal branch guidewire was withdrawn, the microcatheter was advanced past the stenotic lesion in the anterior descending artery, and a rotational atherectomy guidewire was exchanged to the distal segment of the anterior descending artery.The 1.5 bsc rotational atherectomy tip was advanced to the calcified lesions in the proximal and mid segments and rotated at 160,000 - 170,000 revolutions per minute for 4 cycles.The non-bsc guidewire was then exchanged to the distal segment of the anterior descending artery, and the 2.5 x 10mm wolverine cutting balloon was advanced to the lesion in the anterior descending artery.The lesion was pre-dilated at 6 - 10 atmospheres, and angiography revealed improvement in the stenosis of the proximal segment of the anterior descending artery.Advance the 2.0 x 15 mm non-bsc drug-eluting balloon to the lesion at the origin of the third diagonal branch of the left anterior descending artery and dilate the balloon at 6 atmospheres for 60 seconds.A 2.5 x 29mm and 3.0 x 13mm non-bsc stents were advanced to the lesion in the mid-segment of the left anterior descending artery (lad).The stents were deployed at 10 atmospheres for 5 seconds.A 3.0 x 12mm non-bsc balloon was used for post-dilatation at 10 - 14 atmospheres.Angiography revealed resolution of the local stenosis, complete stent expansion, and good wall adherence.With distal blood flow in the left anterior descending artery and diagonal branch reaching timi class 3.The procedure proceeded smoothly; intraoperative ecg and blood pressure readings were normal; the patient reported no significant discomfort and was returned to the ward postoperatively.The patient returned to the hospital 5 weeks later for treatment of a right coronary artery lesion.
Additional Manufacturer Narrative
E1: initial reporter city: (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: 50884197
• Report Number: 2124215-2026-50897
• Device Sequence Number: 10717967
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: H7493892815250
• Device Catalogue Number: H7493892815250
• Device Lot Number: 0038351406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 01/15/2026
• 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: 57 YR
• Patient Sex: Male