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

Model Number	7010
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on investigation results on 11-dec-2018.It was reported that the device kinked.A quantum maverick balloon catheter was selected use and it was noted to be kinked.The device was exchanged and there were no patient complications reported.However analysis results revealed a shaft break.Device evaluated by manufacturer: returned device consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded and there was blood in the wire lumen.The hypotube, distal shaft, balloon and tip were microscopically and visually inspected.Inspection revealed a complete separation in the hypotube located 72.3 cm from the strain relief, and numerous small kinks in the hypotube, and numerous small kinks in the distal shaft.The fracture facets of the fractured shaft were ovalized, as if kinked prior to separation.Microscopic inspection found the remainder of the device free of damage.

• Brand Name: QUANTUM 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: 8185498
• Report Number: 2134265-2018-64588
• Device Sequence Number: 19206961
• Product Code: LOX
• UDI-Device Identifier: 08714729392729
• UDI-Public: 08714729392729
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 11/19/2020
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021412917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1