MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF10-F20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	11/03/2020
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
During the procedure, a tamponade occurred.While mapping the right upper pv, the patient became hypotensive and a transthoracic echocardiogram was performed which revealed a cardiac tamponade.The patient was intubated and a pericardiocentesis was performed to stabilize the patient.Patient is currently in stable condition and is recovering.There were no performance issues with any abbott devices.
Additional Manufacturer Narrative
Additional information: d10, g4, h2, h3, h6.One 20 pole, bi-directional, curve d-f, sensor enabled, advisor vl circular mapping catheter was received for evaluation.Electrodes 1-22 met specifications for acceptable resistance values with no open or short circuits detected.The catheter deflected when actuating the steering mechanism and the curve dimensions met specifications.Microscopic analysis revealed no rough edges or visual anomalies with the loop or shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue remains unknown.

• Brand Name: ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER
• 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: 10894881
• Report Number: 3008452825-2020-00626
• Device Sequence Number: 16950861
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160335
• 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,Followup
• Report Date (Section B): 12/10/2020

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: 08/31/2023
• Device Model Number: D-AVSE-DF10-F20
• Device Catalogue Number: D-AVSE-DF10-F20
• Device Lot Number: 7653383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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: Required Intervention