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

Model Number	7580
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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 severely tortuous and moderately calcified coronary artery.After the lesion was pre-dilated using a semi compliant balloon, a 2.00mm x 12mm maverick balloon catheter was advanced for dilation.However, during second inflation at high pressure, the balloon failed to dilate and was ruptured.The device was removed and completed the procedure with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 2.00mm x 12mm was returned for analysis.Visual and tactile inspection revealed no issues with the hypotube shaft.No issues identified with the hypotube shaft.A severe kink was identified in the midshaft approximately 32.5cm from the distal tip.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.There was no trace of contrast/inflation media present in the balloon.Bumper tip showed no signs of distal tip damage.The device was attached to an encore inflation unit, and an inflation attempt was performed.Inflation media did not reach the balloon, but no leak was detected.It was determined that due to the kink in the midshaft that the device could not inflate so destructive testing was performed, and the device was cut distally to the kink.Another inflation attempt was performed using an inflation aid and while it was possible to inflate liquid into the balloon (with no evidence of a leak), the balloon could not maintain pressure at 14 atmospheres, due to the fact that liquid was leaking at the connection with the dissected shaft and inflation aid.The encore device was verified before use by using the druck gauge.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.After the lesion was pre-dilated using a semi compliant balloon, a 2.00mm x 12mm maverick balloon catheter was advanced for dilation.However, during second inflation at high pressure, the balloon failed to dilate and was ruptured.The device was removed and completed the procedure with another of the same device.There were no patient complications reported.

• 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: 19635465
• Report Number: 2124215-2024-39036
• Device Sequence Number: 20606353
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/26/2025

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: 11/21/2025
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0030583226
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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 Sex: Male