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

Model Number	7580
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, concentric, de novo target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.After engaging the lesion with a non-boston scientific (bsc) guide catheter and crossed with a non-bsc guide wire, a 2.00mm x 12mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with a 2.50 x12 nc quantuma apex balloon catheter.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, concentric, de novo target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.After engaging the lesion with a non-boston scientific (bsc) guide catheter and crossed with a non-bsc guide wire, a 2.00mm x 12mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres, the balloon ruptured.The procedure was completed with a 2.50 x12 nc quantuma apex balloon catheter.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
The returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There was both contrast and blood in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was soaked for a period of time to loosen up the blood and contrast within the device.It was then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 5mm from the tip of the device.The device failed to inflate to rated burst pressure.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12565565
• Report Number: 2134265-2021-12373
• Device Sequence Number: 13793286
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 12/14/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0026512237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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: Unknown