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

Model Number 7010

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 09-oct-2018.It was reported that shaft damage occurred.The target lesion was located in a coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was selected for use.During preparation, the balloon was found to be failed out of the shaft.No patient complications were reported.However, returned device analysis revealed shaft detached.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 the hypotube is separated 83.8cm from the hub.There are multiple kinks along the whole device.Microscopic examination revealed no damages and the balloon is still tightly folded.There is blood present on the balloon folds and in the guidewire lumen.Although it was reported that the device was not used, the presence of blood on the balloon and in the guidewire lumen is indicative of handling beyond simply prepping the device, as was reported.Inspection of the remainder of the device presented no other damage or irregularities.The separated hypotube appeared to be kinked prior to separation.

• 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: 8016756
• MDR Text Key: 125443786
• Report Number: 2134265-2018-62443
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: 08714729392699
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2020
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021372473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2017
• 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