MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	A-FASE-FF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/25/2018
Type of Reportable Event	Death
Event or Problem Description
Related manufacturer reference number: 3005334138-2018-00197, 3008452825-2018-00232, 2182269-2018-00086.During a ventricular tachycardia ablation procedure, the patient became hypotensive and expired.After transseptal access was obtained and mapping of the left ventricle was performed, the patient became hypotensive.An echocardiogram was performed but there was no presence of a pericardial effusion or cardiac perforation.The patient¿s blood pressure continued to drop and he subsequently died.The cause of the death is unknown but thought to be due to respiratory failure or preexisting patient conditions.There were no alleged deficiencies with any abbott devices.
Additional Manufacturer Narrative
One flexibility sensor enabled ablation catheter was received for evaluation.No visual anomalies were noted.The catheter met specifications for electrical and temperature testing, and met acceptable irrigation rates during a flow test.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported death cannot be conclusively determined.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 7697784
• Report Number: 3008452825-2018-00231
• Device Sequence Number: 1118463
• Product Code: OAD
• UDI-Device Identifier: 05415067020079
• UDI-Public: 05415067020079
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/19/2018

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: 10/31/2018
• Device Model Number: A-FASE-FF
• Device Lot Number: 6216209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/19/2018
• 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: AGILIS INTRODUCER; BRK TRANSSEPTAL NEEDLE; SWARTZ INTRODUCER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR
• Patient Weight: 75