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

Model Number	7005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 kinks on the hypotube at 29.5cm and 63cm from the hub.Microscopic examination revealed damage to the tip and a longitudinal tear in the balloon 6mm from the tip that is approximately 10mm long.There is contrast present in the inflation lumen and balloon.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.A 3.75mm x 8mm quantum maverick balloon catheter was returned without any reported issue.However, returned device analysis revealed longitudinal balloon tear.

• 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: 8487591
• Report Number: 2134265-2019-03470
• Device Sequence Number: 2689812
• Product Code: LOX
• UDI-Device Identifier: 08714729392590
• UDI-Public: 08714729392590
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/05/2019

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: 10/31/2019
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 19845118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR