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

Model Number	H7493892815250
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	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported, and patient is in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: fg maverick 2 mr, 2.50mm x 15mm was returned for analysis.A visual, tactile, microscopic examination, wire insertion test and leakage test were performed.A visual and tactile examination identified multiple kinking along the length of the hypotube shaft.A visual and tactile examination of the distal shaft polymer extrusion identified no damage.A microscopic examination of the distal extrusion identified that the inner lumen was stretched at various locations along its length, including inside the balloon.Due to the stretching in the inner/wire lumen, it was not possible to load a 0.014inch size guidewire through the wire lumen.A microscopic examination of the balloon material identified no damages.The device was attached to a pre-tested encore inflation unit and the balloon inflated to its rated burst pressure (rbp) of 14 atmospheres with no leaks noted.A vacuum was applied and the balloon deflated.The balloon was inflated two more times and on each occasion the balloon fully inflated to its rbp and maintained pressure with no leaks.The balloon was exhibited signs of having been inflated and was not refolded.A microscopic examination of the tip identified no damages.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported, and patient is in good condition post-procedure.

• 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: 20667873
• Report Number: 2124215-2024-71097
• Device Sequence Number: 8207826
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: 08714729370086
• 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): 03/10/2025

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: H7493892815250
• Device Catalogue Number: H7493892815250
• Device Lot Number: 0033907829
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: 67 YR
• Patient Sex: Male