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

Model Number	7005
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10034663
• Report Number: 2134265-2020-05593
• Device Sequence Number: 2714991
• Product Code: LOX
• UDI-Device Identifier: 08714729392613
• UDI-Public: 08714729392613
• 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,Followup,Followup
• Report Date (Section B): 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/08/2020; 06/09/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/03/2020; 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 72