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

Model Number	7005
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst and the shaft fractured.

• 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: 9746077
• Report Number: 2134265-2020-01879
• Device Sequence Number: 2483351
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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): 02/24/2020

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: 01/13/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023181004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR