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

Model Number	7920
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)
Date of Event	10/16/2020
Type of Reportable Event	Death
Event or Problem 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 or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10942531
• Report Number: 2134265-2020-16908
• Device Sequence Number: 2763729
• Product Code: DQO
• UDI-Device Identifier: 08714729188889
• UDI-Public: 08714729188889
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: Death