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 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, during third inflation at nominal pressure for 15 seconds, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported, and patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: fg maverick 2 mr, 1.50mm x 15mm was returned to the complaint investigation site (cis).A visual and tactile examination identified no issues with the hypotube shaft.A visual, tactile and microscopic examination identified no issues with the outer / mid-shaft sections or the inner lumen of the device, and no issues identified during examination of the extrusion shaft.A detailed microscopic examination of the balloon material identified pinhole in the balloon.A pinhole was located in the balloon material above the markerband.A microscopic examination of the markerband identified no damage.Bumper tip showed signs of distal tip damage.A leakage testing was performed.The device was attached to an encore inflation unit.A pinhole was located above the markerband of the balloon when inflating to rated burst pressure of 14 atmospheres.The encore device was verified before and after use using the druck gauge.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilation.However, during third inflation at nominal pressure for 15 seconds, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported, and 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: 20246181
• Report Number: 2124215-2024-58276
• Device Sequence Number: 15295196
• 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
• Report Date (Section B): 12/01/2024

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: 0032808510
• 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: 11/21/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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: 78 YR
• Patient Sex: Male