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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombus (2101)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 3008452825-2020-00604.After a paroxysmal atrial fibrillation ablation procedure, a blood clot was noted to be attached to the electrode 7.An echocardiogram was performed after the procedure, and no floating substance/material like a blood clot was found in the left atrium and there were no adverse consequences to the patient.

Manufacturer Narrative

One 20 pole, bi-directional, curve d-f, sensor enabled, advisor vl circular mapping catheter loop was received for evaluation.The distal shaft was cut and the loop was returned.The catheter was not returned.A blood like substance was noted on electrodes 7,8, 13 and 14.Functional testing was not possible due to the condition of the returned catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the blood like substance remains unknown.

• Brand Name: ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10859757
• MDR Text Key: 216833446
• Report Number: 3005334138-2020-00548
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (y/n): N
• PMA/PMN Number: K192037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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
• Device Operator: 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: 7359420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH SE; TACTICATH SE
• Patient Outcome(s): Other
• Patient Weight: 64