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

Model Number	H7493892820200
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified right coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced but could not cross the lesion.However, during the procedure, it was noticed that the balloon burst.The procedure was completed with another of the same device without any patient complications reported, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device fg maverick 2 mr, 2.00mm x 20mm was returned to the complaint investigation site (cis) for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the shaft multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified a pinhole leak 2mm proximal to the distal markerband and tip showed no signs of tip damage.The device was attached to an encore inflation device.An attempt was then made to inflate the balloon, however, it was observed that a leak was occurring.A pinhole leak was identified 2mm proximal to the distal markerband.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified right coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced but could not cross the lesion.However, during the procedure, it was noticed that the balloon burst.The procedure was completed with another of the same device without any patient complications reported, and the patient status 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: 21286866
• Report Number: 2124215-2025-05083
• Device Sequence Number: 9529505
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)260619(10)31852534
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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 Expiration Date: 06/19/2026
• Device Model Number: H7493892820200
• Device Catalogue Number: H7493892820200
• Device Lot Number: 0031852534
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Male