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

Model Number 7010

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Reportable based on investigation results on 11-dec-2018.It was reported that the device kinked.A quantum maverick balloon catheter was selected use and it was noted to be kinked.The device was exchanged and there were no patient complications reported.However analysis results revealed a shaft break.Device evaluated by manufacturer: returned device consisted of a quantum maverick balloon catheter in two pieces.The balloon was loosely folded and there was blood in the wire lumen.The hypotube, distal shaft, balloon and tip were microscopically and visually inspected.Inspection revealed a complete separation in the hypotube located 72.3 cm from the strain relief, and numerous small kinks in the hypotube, and numerous small kinks in the distal shaft.The fracture facets of the fractured shaft were ovalized, as if kinked prior to separation.Microscopic inspection found the remainder of the device free of damage.

• Brand Name: QUANTUM MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8185498
• MDR Text Key: 131044920
• Report Number: 2134265-2018-64588
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392729
• UDI-Public: 08714729392729
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021412917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1