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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, the ring portion of the catheter became entangled with the chordae tendineae in the ventricle.Immediately after the entanglement, the doctor tried to remove catheter by turning the handle clockwise, which did not release the device.The physician attempted removal for approximately 30 minutes without success.The vl catheter was placed in the ventricle and only a pvi was performed.The procedure was completed without replacing the catheter.After that, it was determined that a thoracotomy operation would be performed to removed the device.On (b)(6) 2021, a thoracotomy was performed to remove the catheter.When the chest was opened, it was noted that the ring portion of the device was entangled with the chordae tendineae and the tip of the ring was sunk into the myocardium.
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 device entanglement remains unknown.
Event or Problem Description
No additional treatment for myocardial damage was performed.The patient was discharged from the hospital in stable condition.

• 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: 12599752
• Report Number: 3005334138-2021-00635
• Device Sequence Number: 14481338
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 01/31/2024
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 7855112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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: 65 YR
• Patient Weight: 67