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

Model Number	H7493892815150
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use.However, it was confirmed that after opening the package, the balloon was fractured.The procedure was completed with a different device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 1.50mm x 15mm was returned for analysis.A visual and tactile examination identified that the device was received in two sections as a result of a break which had occurred in the hypotube.The break was located at 67cm distal to the distal end of the strain relief.A visual and tactile examination of the distal extrusion identified no damages.A microscopic examination of the balloon material identified no tears or holes in the balloon material.A microscopic examination of the tip identified no damages.A microscopic examination of the markerbands identified no damage.Using an inflation aid, which was attached to the broken section of the hypotube, the aid was attached to a pretested encore inflation unit.It was possible to inflate the balloon to its rated burst pressure (rbp) of 12 atmospheres, with no leaks noted.The balloon was deflated and re-inflated on three more occasions with no leaks noted in the balloon.The balloon maintained pressure each time it was inflated.B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use.However, it was confirmed that after opening the package, the balloon was fractured.The procedure was completed with a different device.There were no patient complications reported.Patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 1.50mm x 15mm was returned for analysis.A visual and tactile examination identified that the device was received in two sections as a result of a break which had occurred in the hypotube.The break was located at 67cm distal to the distal end of the strain relief.A visual and tactile examination of the distal extrusion identified no damages.A microscopic examination of the balloon material identified no tears or holes in the balloon material.A microscopic examination of the tip identified no damages.A microscopic examination of the markerbands identified no damage.Using an inflation aid, which was attached to the broken section of the hypotube, the aid was attached to a pretested encore inflation unit.It was possible to inflate the balloon to its rated burst pressure (rbp) of 12 atmospheres, with no leaks noted.The balloon was deflated and re-inflated on three more occasions with no leaks noted in the balloon.The balloon maintained pressure each time it was inflated.B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use.However, it was confirmed that after opening the package, the balloon was fractured.The procedure was completed with a different device.There were no patient complications reported.Patient was stable.

• 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: 21753902
• Report Number: 2124215-2025-20379
• Device Sequence Number: 18553713
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)270927(10)34940862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2025

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: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0034940862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 11/14/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/30/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG