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

Model Number	7005
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 12-sep-2018.It was reported that balloon inflation failure occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, the balloon was unable to be dilated by encore inflation device.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.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 a kink 88mm from the hub.Microscopic examination revealed a pinhole sized tear 11mm from the tip.Further examination revealed the tip and exit hub is damaged.The balloon is loosely folded and there is blood present in the shaft and in the balloon.Inspection of the remainder of the device presented no other damage or irregularities.The complaint investigation conclusion code is: adverse event related to procedure.

• 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: 7942265
• Report Number: 2134265-2018-61632
• Device Sequence Number: 16336127
• 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): 10/08/2018

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: 03/01/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0021810745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1