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

Model Number	7590
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located at the moderately tortuous and moderately calcified right coronary artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.There was no patient injury reported and the patient's condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located at the moderately tortuous and moderately calcified right coronary artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.There was no patient injury reported and the patient's condition was good.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube of the device.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.There was a 7mm longitudinal tear, 14mm from the tip.The tip of the device was damaged.

• 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: 12565598
• Report Number: 2134265-2021-12379
• Device Sequence Number: 11102892
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 03/21/2024
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0027007517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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: 53 YR
• Patient Sex: Male