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

Model Number	H7493892820200
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Device evaluated by mfr: an fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.Visual and tactile inspection identified the balloon had been subjected to positive pressure and returned in a deflated state.A hypotube kink was identified at 1.3cm distal to the distal end of the strain relief.Microscopic analysis identified no kinks or damages on the shaft polymer extrusion, no issues noted with the bumper tip, and no damaged to the distal and proximal markerbands.A leakage testing was performed where the device was attached to an encore inflation unit and an attempt was made to inflate the balloon however, under microscopic analysis, a pinhole was identified above the proximal markerband.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on device analysis completed on 14nov2025.It was reported that balloon leak occurred.The 25% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.00mm x 20mm maverick? balloon catheter was advanced for pre-dilation.Upon reaching the lesion site, the balloon was observed to be leaking water from the tip of the device.No visible pinhole was noted at that time.The balloon was replaced with another of the same device, and a stent was successfully implanted.No patient complications were reported, and the patient remained stable post-procedure.However, returned device analysis revealed a balloon pinhole.

• 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: 23717495
• Report Number: 2124215-2025-88905
• Device Sequence Number: 8982207
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)280124(10)35701556
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: H7493892820200
• Device Catalogue Number: H7493892820200
• Device Lot Number: 0035701556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 66 KG