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

Model Number	7590
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the third inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the fg maverick 2 mr, 2.00mm x 20mm, catheter was returned for analysis.A visual, tactile, microscopic analysis, and leakage testing were performed on the device.A visual and tactile examination identified no kinks or damages along the length of the hypotube.No issues identified with the distal extrusion.A pinhole was identified in the balloon material.The pinhole was located over the proximal markerband.Tip showed no signs of tip damage.A microscopic examination of the markerband's identified no damage.Using an encore inflation unit an attempt was made to inflate the balloon when a pinhole leak was noted in the balloon.The pinhole was located over the proximal markerband.No other damages were observed along the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the third inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with another of the same 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: 19967891
• Report Number: 2124215-2024-49970
• Device Sequence Number: 15677972
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• 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): 10/31/2024

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: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0034033480
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 83 YR
• Patient Sex: Male