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

Model Number	7585
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion, which was 85% stenosed, was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured at its rated burst pressure.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
The device was returned for analysis.A visual and tactile inspection revealed no issues identified with the hypotube shaft.No kinks or damages.To the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified a 2.1cm balloon tear.Tip showed no signs of tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion, which was 85% stenosed, was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured at its rated burst pressure.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient was 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20290644
• Report Number: 2124215-2024-59599
• Device Sequence Number: 8086065
• 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): 11/04/2024

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 Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0033930500
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/20/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: 61 YR
• Patient Sex: Female