MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG; DIAGNOSTIC EP CATHETER

Model Number	401878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
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 pericardial effusion may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During an atrial tachycardia ablation procedure, a pericardial effusion was noted.Following ablation in the non-coronary cusp of the aorta, the ablation catheter was removed.When pulling back the diagnostic catheters at the end the procedure, the patient became hypotensive and hypoxic.An echocardiogram revealed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.The patient is being monitored.There were no performance issues with any abbott devices.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, HEXAPOLAR (UNIPOLAR RECORDING), 120 CM LENG
• Common Device Name: DIAGNOSTIC EP 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: 7813751
• Report Number: 3008452825-2018-00276
• Device Sequence Number: 1991303
• Product Code: DRF
• UDI-Device Identifier: 05414734201629
• UDI-Public: 05414734201629
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 04/30/2021
• Device Model Number: 401878
• Device Lot Number: 6469517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/24/2018
• 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: ADVISOR HD GRID CATHETER; COOL POINT TUBING SET; ENSITE PRECISION ELECTRODE KIT; LIVEWIRE EP CATHETER; TACTICATH ABLATION CATHETER; UNKNOWN 5F QUADRIPOLAR CATHETER; UNKNOWN 5F QUADRIPOLAR, CRD CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR