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	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
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, the distal electrode was noted to be stuck in the chorda tendinea around the tricuspid valve.The catheter could no longer be operated.The catheter was removed from the patient by applying torque to the catheter shaft several times but the loop was found to be elongated vertically.No further intervention was needed to remove the device.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6, h10.One advisor¿ vl, sensor enabled¿ circular mapping catheter was received for investigation.Five images were submitted to product performance engineering.The images appear to show the elongated and stretched loop.Upon device investigation, the loop was stretched vertically and no longer held the correct shape.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported stretched loop is consistent with damage during use.

• 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: 10254492
• Report Number: 3005334138-2020-00291
• Device Sequence Number: 14097716
• Product Code: DRF
• UDI-Device Identifier: 05415067027283
• UDI-Public: 05415067027283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192037
• 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): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 7239316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1