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

Model Number	D-AVSE-DF10-F15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturing ref: 3008452825-2020-0723, 3008452825-2020-00724, 3005334138-2020-00646, 3008452825-2020-00726.Two days post atrial fibrillation ablation procedure, a pericardial effusion was noted via transthoracic echocardiography.Serohematic fluid was drained which stabilized the patient.There were no performance issues with any abbott devices.
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 incident could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

• Brand Name: ADVISOR FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED
• 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: 11060862
• Report Number: 3008452825-2020-00725
• Device Sequence Number: 2875943
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 03/31/2022
• Device Model Number: D-AVSE-DF10-F15
• Device Catalogue Number: D-AVSE-DF10-F15
• Device Lot Number: 7685625
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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: BRK¿ XS TRANSSEPTAL NEEDLE; INQUIRY EP CATHETERS; SWARTZ BRAIDED INTRODUCER; TACTICATH ABLATION CATHETER SE; BRK¿ XS TRANSSEPTAL NEEDLE; INQUIRY EP CATHETERS; SWARTZ BRAIDED INTRODUCER; TACTICATH ABLATION CATHETER SE
• Outcome Attributed to Adverse Event: Required Intervention