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

Model Number	H7493892820250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Bradycardia (1751); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Reduced Blood Flow (4598)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred resulting in reduced blood flow, chest pain, hypotension, and bradycardia which required treatment.The patient presented with acute myocardial infarction.The target lesion was located in the left anterior descending artery (lad).A 2.50mm x 20mm maverick 2 balloon catheter was advanced for dilation.However, when the balloon reached 12 atmospheres, the balloon ruptured resulting in interruption of blood flow in the lad.The patient experienced chest pain, low blood pressure, and slow heart rate.Medication was administered immediately and the patient symptoms improved.The balloon was removed, and the procedure was completed with a different device.There were no further patient complications reported.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred resulting in reduced blood flow, chest pain, hypotension, and bradycardia which required treatment.The patient presented with acute myocardial infarction.The target lesion was located in the left anterior descending artery (lad).A 2.50mm x 20mm maverick 2 balloon catheter was advanced for dilation.However, when the balloon reached 12 atmospheres, the balloon ruptured resulting in interruption of blood flow in the lad.The patient experienced chest pain, low blood pressure, and slow heart rate.Medication was administered immediately and the patient symptoms improved.The balloon was removed, and the procedure was completed with a different device.There were no further patient complications reported.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: fg maverick 2 mr, 2.50mm x 20mm was returned for analysis.A visual and tactile examination identified multiple kinking along the length of the hypotube.A visual and tactile examination of the distal extrusion identified no damages.A microscopic examination of the distal extrusion identified no damages.A microscopic examination of the balloon material identified an 8mm longitudinal tear in the balloon material.This tear stretched from the proximal markerband to mid section of balloon.A microscopic examination of the tip identified no damages.A microscopic examination of the markerbands identified no damages.

• 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: 20995881
• Report Number: 2124215-2024-79273
• Device Sequence Number: 8054588
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• 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): 02/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2026
• Device Model Number: H7493892820250
• Device Catalogue Number: H7493892820250
• Device Lot Number: 0031412932
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 75 KG