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

Model Number	7005
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 29sep2018.It was reported that shaft kink occurred.The stenosed target lesion was located in a coronary artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the shaft was kinked.The procedure was completed with another of the same device.No complications were reported and the patients status was stable.However, returned device analysis revealed shaft detached.Device evaluated by manufacturer: the returned product consisted of a quantum maverick balloon.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a separation in the hypotube at 84cm from the hub.There are multiple kinks along the whole device.Microscopic examination did not reveal any damages.There is blood present in the guidewire lumen and the balloon is tightly 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: 7995887
• Report Number: 2134265-2018-62220
• Device Sequence Number: 203194
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: 08714729392552
• 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
• Report Date (Section B): 10/23/2018

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: 05/04/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0020609468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1