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	04/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the right coronary artery (rca).After a mach 1 guiding catheter and a non-bsc guide wire were used for cannulation on the ostial to distal rca, a 3.00mm x 15mm maverick balloon catheter was advanced for pre-dilatation.However, when the balloon catheter was not yet fully inside the guide catheter, it was noted that the shaft broke 64cm from the proximal shaft.The device was simply removed and was replaced with a 4.0x12mm nc emerge balloon catheter to open the proximal rca and another 2.5x20mm maverick balloon catheter was used to open the mid rca.The procedure was completed with plain old balloon angioplasty.No patient complications were reported and the patient's status was stable.

• 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: 8574892
• Report Number: 2134265-2019-04742
• Device Sequence Number: 245060
• Product Code: LOX
• UDI-Device Identifier: 08714729370109
• UDI-Public: 08714729370109
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Report Date (Section B): 05/02/2019

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: 09/10/2021
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0022635503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1