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

Model Number	7005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 5.0mm x 8mm quantum maverick balloon catheter was selected but delivery shaft of the balloon was fractured near the hub.The device was simply removed as a whole all together.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 5.0mm x 8mm quantum maverick balloon catheter was selected but delivery shaft of the balloon was fractured near the hub.The device was simply removed as a whole all together.No patient complications were reported.Returned product consisted of a quantum maverick balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed two separations in the hypotube.One separation is 43.5cm from the hub and the other is 67.7cm from the tip.There are multiple kinks along the whole device.Microscopic examination revealed no additional damages.There is blood present in the inflation lumen, guidewire lumen, balloon and hub.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8103598
• Report Number: 2134265-2018-63137
• Device Sequence Number: 19338982
• Product Code: LOX
• UDI-Device Identifier: 08714729392620
• UDI-Public: 08714729392620
• 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): 01/08/2019

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: 11/14/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0021393058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1