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

Model Number	7585
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	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilation.However, the balloon ruptured before passing through the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilation.However, the balloon ruptured before passing through the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during fifth inflation at 12 atmospheres.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.The device was returned for analysis.A visual and tactile inspection revealed no issues identified with the hypotube shaft.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.A microscopic analysis revealed that the balloon appeared to have been subjected to positive pressure however there were no signs of damage to the balloon material.A microscopic examination of the markerband identified no damage and bumper tip showed no signs of distal tip damage.A leakage test was performed.The device was attached to an encore inflation unit and the balloon was inflated to rated burst pressure (14 atmospheres).No leaks or tears were found.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilation.However, the balloon ruptured before passing through the lesion.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during fifth inflation at 12 atmospheres.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19187910
• Report Number: 2124215-2024-24660
• Device Sequence Number: 7280684
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: 08714729370055
• 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,Followup
• Report Date (Section B): 07/12/2024

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: 07/25/2026
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0032088677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/01/2024; 07/09/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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: 65 YR
• Patient Sex: Male