MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/27/2020
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 remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturing ref: 3008452825-2020-00399, 3008452825-2020-00404, 3008452825-2020-00405, 2182269-2020-00071.During a premature ventricular contraction (pvc) procedure, a pericardial effusion occurred.After 2 hours, the patient became hypotensive and an ultrasound revealed a pericardial effusion.A pericardiocentesis was performed and the patient was stable when leaving the room.However, the patient was then transferred to surgery for repair and is in stable condition.There were no performance issues with any abbott devices.

• Brand Name: SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 10414091
• Report Number: 3008452825-2020-00406
• Device Sequence Number: 19638325
• Product Code: DRF
• UDI-Device Identifier: 05414734201285
• UDI-Public: 05414734201285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K894500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 02/28/2023
• Device Model Number: 401430
• Device Catalogue Number: 401430
• Device Lot Number: 7456986
• 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: 07/27/2020
• Initial Report FDA Received Date: 08/17/2020
• 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: AGILIS¿ NXT INTRODUCER.; BRK¿ XS NEEDLE.; INQUIRY¿ STEERABLE CATHETER.; LIVEWIRE¿ EP CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention