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

Model Number	H7493892815200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with acute myocardial infarction and underwent emergency coronary intervention.The 80% stenosed target lesion was located in the moderately tortuous and moderately to severely calcified proximal to middle segment of the anterior descending branch.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the third inflation at 14 atmospheres for 10 seconds, the inflation pressure failed to rise and the balloon ruptured, which occurred when severe vascular calcification was encountered.Subsequently, a high-pressure balloon was used for dilatation, and the treatment was completed successfully.There were no patient complications.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Investigation results: 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 are 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.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 patient condition as it is most likely that anatomical factors (80% stenosed, moderately tortuous and moderately to severely calcified) were met which resulted in the reported event.This conclusion code is based on the available information and the review conducted at the boston scientific site.The device was not returned for analysis therefore the reported balloon rupture cannot be confirmed.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with acute myocardial infarction and underwent emergency coronary intervention.The 80% stenosed target lesion was located in the moderately tortuous and moderately to severely calcified proximal to middle segment of the anterior descending branch.A 2.00mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the third inflation at 14 atmospheres for 10 seconds, the inflation pressure failed to rise and the balloon ruptured, which occurred when severe vascular calcification was encountered.Subsequently, a high-pressure balloon was used for dilatation, and the treatment was completed successfully.There were no patient complications.

• 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: 24941255
• Report Number: 2124215-2026-21473
• Device Sequence Number: 5585654
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)280721(10)37025891
• 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): 05/27/2026

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: 0037025891
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 07/22/2025
• 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
• Patient Age: 79 YR
• Patient Sex: Female