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

Model Number	7585
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 100% stenosed, 2.5mm x 35mm, target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.00mm x 15mm maverick balloon catheter was advanced for dilation.However, during the procedure, it was noted that the shaft was fractured and the balloon failed to cross the chronic total occlusion lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that a shaft break occurred.The 100% stenosed, 2.5mm x 35mm, target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 3.00mm x 15mm maverick balloon catheter was advanced for dilation.However, during the procedure, it was noted that the shaft was fractured and the balloon failed to cross the chronic total occlusion lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.It was further reported that the device was completely removed.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10043330
• Report Number: 2134265-2020-06272
• Device Sequence Number: 19434310
• Product Code: LOX
• UDI-Device Identifier: 08714729370109
• UDI-Public: 08714729370109
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 02/06/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0021716496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65