MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	10/05/2020
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.
Event or Problem Description
Related mfr numbers: 3008452825-2020-00536, 3005334138-2020-00479, 3005334138-2020-00478.During an atrial fibrillation procedure, a pericardial effusion occurred, a pericardiocentesis was performed, and the case was abandoned.A non-abbott cryo-balloon ablation catheter was used after transseptal puncture on the left superior pulmonary vein and left inferior pulmonary vein.When it was used to cryo-ablate the right inferior pulmonary vein, phrenic nerve pacing stopped simulating the right hemi-diaphragm.The catheter was repositioned in the superior vena cava numerous times to try to reestablish phrenic nerve stimulation.Cryo was stopped, the balloon catheter was removed and replace with a tacticath se.The tacticath se was used for radio frequency wide-area circumferential ablation near the right inferior pulmonary vein.Hypotension was noted, and the ice catheter showed a pericardial effusion.Ablation was stopped, catheters were removed, and pericardiocentesis was started.The pericardiocentesis removed 450ml from the effusion.The patient was intubated and went to the icu.It was not clear which catheter or maneuver caused the effusion, or where the suspected perforation was located.Heparin was used.There were no performance issues with any abbott 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; 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: 10754674
• Report Number: 3008452825-2020-00535
• Device Sequence Number: 3486412
• Product Code: DRF
• UDI-Device Identifier: 05414734201377
• UDI-Public: 05414734201377
• 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,Followup
• Report Date (Section B): 11/06/2020

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: 04/30/2023
• Device Model Number: 401443
• Device Catalogue Number: 401443
• Device Lot Number: 7532044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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: ADVISOR¿ HD GRID MAPPING CATHETER SENSOR ENABLED¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; TACTICATH¿ CONTACT FORCE CATHETER SENSOR ENABLED¿; ADVISOR¿ HD GRID MAPPING CATHETER SENSOR ENABLED¿; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; TACTICATH¿ CONTACT FORCE CATHETER SENSOR ENABLED¿
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 96