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

Model Number	H7493892812250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.50 mm x 12 mm maverick 2 balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured, and the balloon catheter did not break into two pieces.The procedure was completed with a different device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital device evaluated by mfr: fg maverick 2 mr, 2.50mm x 12mm balloon catheter was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 74cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A microscopic examination of the balloon material identified no pinholes, tears or damage to the balloon.Bumper tip showed no signs of distal tip damage.A leakage testing identified the balloon was inflated to 14 atmospheres as per instructions for use using an inflation aid due to the break in the hypotube.The balloon inflated without issues; however, the balloon could not maintain pressure due to the technique used.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.50 mm x 12 mm maverick 2 balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured, and the balloon catheter did not break into two pieces.The procedure was completed with a different device.No patient complications were 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: 20935426
• Report Number: 2124215-2024-79225
• Device Sequence Number: 9073016
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• 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,Followup
• Report Date (Section B): 02/03/2025

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: H7493892812250
• Device Catalogue Number: H7493892812250
• Device Lot Number: 0033544965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/15/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG