MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE; DIAGNOSTIC EP CATHETER

Model Number	401442
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of an effusion was reported.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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
Related manufacturer report number: 9680001-2018-00084, 3005334138-2018-00174, 3008452825-2018-00195, 2182269-2018-00080, 3008452825-2018-00196, 3008452825-2018-00198.During a ventricular tachycardia procedure, a pericardial effusion occurred.An elderly patient who was very pro-arrhythmic during the vt procedure, with a systolic blood pressure (sbp) of 100 from the initiation of the procedure.While the tacticath was being manipulated in the ventricle, the patient's sbp decreased to 85-90, the procedure was paused and after 30 minutes the bp remained low an echocardiogram revealed a small pericardial effusion.While prepping to perform a pericardiocentesis the patient's bp dropped and the patient decompensated.A catheter was introduced into the coronary sinus for pacing and a pericardiocentesis and blood transfusion were performed to stabilize the patient.There were no performance issues with any abbott device.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE
• Common Device Name: DIAGNOSTIC EP CATHETER
• 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: 7630752
• Report Number: 3008452825-2018-00194
• Device Sequence Number: 14081487
• Product Code: DRF
• UDI-Device Identifier: 05414734201360
• UDI-Public: 05414734201360
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K002976
• 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
• Report Date (Section B): 06/22/2018

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: 10/31/2020
• Device Model Number: 401442
• Device Lot Number: 6205302
• 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: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• 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 MAPPING CATHETER, SENSOR ENABLED; AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿; BRK¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention