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

Model Number	401442
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Perforation (2513)
Date of Event	01/27/2020
Type of Reportable Event	Death
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 cardiac perforation and subsequent patient expiration could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During a crt-d implantation procedure a cardiac tamponade and subsequent patient expiration occurred.The diagnostic catheter was used for coronary sinus (cs) cannulation.While implanting the leads there was difficulty advancing past the cs but eventually the leads were able to overpass the valve.Once past the valve the patient became hypotensive and an echocardiogram revealed blood in the pericardium.A pericardiocentesis was performed to stabilize the patient however cardiopulmonary resuscitation was needed.The patient expired following intervention.There were no performance issues with any abbott device.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); 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: 9720001
• Report Number: 3008452825-2020-00088
• Device Sequence Number: 11363077
• Product Code: DRF
• UDI-Device Identifier: 05414734201360
• UDI-Public: 05414734201360
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/18/2020

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: 09/30/2022
• Device Model Number: 401442
• Device Catalogue Number: 401442
• Device Lot Number: 7219617
• 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: 01/27/2020
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 79 YR