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

Model Number	7585
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified middle circumflex (cx).A 3.00mm x 15mm maverick was advanced but couldn't reach the target lesion by 2cm.The balloon was pulled back into the guide catheter, and while pulling the device inside the guide catheter, the shaft broke approximately 25 cm from hub.The device was completely located within the guide catheter.The procedure was completed with another of the same device.No patient complications were reported in relation to this event.

• 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: 8251234
• Report Number: 2134265-2018-64917
• Device Sequence Number: 11161448
• Product Code: LOX
• UDI-Device Identifier: 08714729370109
• UDI-Public: 08714729370109
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: 11/13/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022937668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1