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

Model Number 7005

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/17/2020

Event Type  Injury  

Event Description

It was reported that pericardial tamponade occurred.During a procedure involving a 4.5mm x 8mm quantum maverick balloon catheter, pericardial tamponade occurred.The procedure was not completed.

Event Description

It was reported that pericardial tamponade occurred.During a procedure involving a 4.5mm x 8mm quantum maverick balloon catheter, pericardial tamponade occurred.The procedure was not completed.It was further reported that the target lesion was located in the left anterior descending artery.During the procedure, due to the early deployment of the device/premature deployment, the patient suffered from pericardial tamponade.The patient was then sent to intensive care unit for salvage for more than 4 hours and the patient was stable afterwards.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that pericardial tamponade occurred.During a procedure involving a 4.5mm x 8mm quantum maverick balloon catheter, pericardial tamponade occurred.The procedure was not completed.It was further reported that the target lesion was located in the left anterior descending artery.During the procedure, due to the early deployment of the device/premature deployment, the patient suffered from pericardial tamponade.The patient was then sent to the intensive care unit for salvage for more than 4 hours and the patient was stable afterwards.

• 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: 10034663
• MDR Text Key: 190320562
• Report Number: 2134265-2020-05593
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392613
• UDI-Public: 08714729392613
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0024485103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 72