MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER, BI-D, CURVE F-J; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A701128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Perforation (2513)
Date of Event	07/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported tamponade could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.Further information regarding the event was requested but not received.
Event or Problem Description
Related manufacturer reference: 3005334138-2020-00362, 3008452825-2020-00417.During a ventricular tachycardia ablation procedure, a cardiac tamponade occurred.Following the transseptal puncture, when attempting the retro aortic technique, a cardiac tamponade was observed.The tamponade was confirmed by echocardiogram located at the left atrial appendage.It is unknown which device caused the tamponade.Defibrillation, cardiac massage and cardiac surgery were performed to treat the patient.The patient expired due to instable hemodynamics.There were no performance issues with any abbott device.
Event or Problem Description
During a ventricular tachycardia ablation procedure, a cardiac tamponade occurred.A transseptal puncture was performed using guided intracardiac echocardiogram and a transesophageal echocardiogram due to anatomical changes in the interatrial septum (hypertrophy).Difficulty was noted maneuvering through the left atrium to the left ventricular with the flexability catheter and the md opted to use a retrograde approach.During this approach, a cardiac tamponade was diagnosed by echocardiogram requiring at thoracotomy for drainage.The patient experienced severe hemorrhagic shock, severe systemic dysfunction refractory to measures of blood products, vasoactive drugs and intra-aortic balloon pump resulting in death.It was unknown when the perforation occurred, or which device caused the tamponade.There were no performance issues with any abbott device.

• Brand Name: FLEXABILITY ABLATION CATHETER, BI-D, CURVE F-J
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10430816
• Report Number: 3008452825-2020-00416
• Device Sequence Number: 2889501
• Product Code: OAD
• UDI-Device Identifier: 05415067011145
• UDI-Public: 05415067011145
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P110016
• 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): 09/21/2020

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: 08/31/2022
• Device Model Number: A701128
• Device Catalogue Number: A701128
• Device Lot Number: 7164601
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; BRK TRANSSEPTAL NEEDLE, 71 CM LENGTH; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER
• Outcome Attributed to Adverse Event: Death