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	401443
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 2182269-2020-00022, 2030404-2020-00013, 3005334138-2020-00072.During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.After the procedure was completed, the patient became hypotensive, so an ultrasound was performed, confirming a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
One 5f, quadripolar, jsn, supreme ep catheter was received for evaluation.Electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.No visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported cardiac perforation cannot be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• 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: 9744990
• Report Number: 3008452825-2020-00113
• Device Sequence Number: 13631866
• Product Code: DRF
• UDI-Device Identifier: 05414734201377
• UDI-Public: 05414734201377
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/06/2020

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: 10/31/2022
• Device Model Number: 401443
• Device Catalogue Number: 401443
• Device Lot Number: 7268488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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 INTRODUCER X2; BRK TRANSSEPTAL NEEDLE; INQUIRY AFOCUS CATHETER; LIVEWIRE CATHETER; TACTICATH SE CATHETER; VIEWFLEX ICE CATHETER; AGILIS INTRODUCER X2; BRK TRANSSEPTAL NEEDLE; INQUIRY AFOCUS CATHETER; LIVEWIRE CATHETER; TACTICATH SE CATHETER; VIEWFLEX ICE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 82