MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 7920

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 10/16/2020

Event Type  Death  

Event Description

It was reported that patient death occurred.Two 5fr impulse guide catheters were used in a diagnostic angiogram procedure.During the procedure, perforation of the non-coronary cusp occurred leading to patient death.

Event Description

It was reported that patient death occurred.Two 5fr impulse guide catheters were used in a diagnostic angiogram procedure.During the procedure, perforation of the non-coronary cusp occurred leading to patient death.It was further reported there were no known issues with the device performance during the procedure.After the catheters were inserted, the patient experienced chest pain and pulseless electrical activity (pea) cardiac arrest with no obvious sign of dissection.Cardiac tamponade occurred.Dissection of the coronary cusp was confirmed on ct.The physician's team's opinion was that a perforation likely occurred when the catheter was inserted.Emergency thoracotomy was performed and the patient was cardiovascularly stable.There was an inability to wean off the ventilator and patient death occurred.

• Brand Name: IMPULSE GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10942531
• MDR Text Key: 219477276
• Report Number: 2134265-2020-16908
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729188889
• UDI-Public: 08714729188889
• Combination Product (y/n): N
• PMA/PMN Number: K120495
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: 7920
• Device Catalogue Number: 7920
• Device Lot Number: 0060252402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death