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-DF20-V1525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of pericardial 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 pericardial effusion may have been procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
Event or Problem Description
During an atrial fibrillation and atrial flutter ablation procedure, a pericardial effusion occurred.Transseptal access was gained to the left atrium and the advisor vl was inserted.There was difficulty navigating and mapping the left atrial appendage.After the map was completed, a second transseptal puncture was performed and the ablation catheter was inserted into the left atrium.Noise was observed on the distal tip of the ablation catheter and it was not locating properly on ensite.No ablation was conducted.Shortly after, the patient became hypotensive.A 2 cm pericardial effusion was observed on ice.The mapping catheter and ablation catheters were moved out of the left atrium.A pericardial tap was performed which stabilized the patient.The patient's hemoglobin and hematocrit count was decreasing despite draining the effusion.A hematoma was identified at the right groin site.The hematoma was caused when achieving venous access at the beginning of the procedure and was not believed to be due to an abbott device.A ct scan was also performed and ruled out retroperitoneal bleed.The patient was intubated and left in stable condition.The physician believes the pericardial effusion was due to the mapping catheter in the left atrial appendage as he was having difficulty navigating the device.There were no performance issues with any abbott device in relation to the effusion.

• 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; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10283104
• Report Number: 3005334138-2020-00303
• Device Sequence Number: 689689
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192037
• 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
• Report Date (Section B): 07/16/2020

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: 12/31/2022
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 7353924
• 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: 07/01/2020
• Initial Report FDA Received Date: 07/16/2020
• 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
• Patient Age: 70 YR