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

Model Number 7015

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a quantum maverick catheter in two pieces.The balloon was tightly folded.The tip, balloon, inner/outer shaft, and hypotube were microscopically and visually inspected.Inspection revealed a fracture in the hypotube located 69.5cm from the tip of the device, with numerous hypotube kinks.The fracture faces of the separation was ovalized, as if kinked prior to separation.Inspection of the rest of the device found no damage or defect with the device.The guide wire used with the device was not returned for analysis.A.014" guide wire was used to functionally test the interaction of the devices.The guide wire was loaded into the tip of the catheter and advanced through the catheter and out from the port/exit notch.

Event Description

Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.

• 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
• MDR Report Key: 8603602
• MDR Text Key: 144824417
• Report Number: 2134265-2019-05166
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022806762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 55