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 Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 12/03/2020

Event Type  Injury  

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 device entrapment and catheter damage could not be conclusively determined.

Event Description

During an atrial fibrillation procedure, when mapping of the left atrium was being performed on the ensite, the catheter entered the left ventricle and became entangled in the chordae tendineae and the papillary muscles, and the catheter could not be removed from there.Torque was applied to the catheter by viewing through the echocardiogram, the catheter was pulled into the sheath, and pacing was applied with the catheter being moved, but the catheter could not be removed.The patient was moved to an operating room in the cardiovascular surgery unit and the catheter was removed by thoracoscopy and a valvuloplasty was performed for torn papillary muscles.It was found that the chordae tendineae and the papillary muscles were torn off and entangled.The catheter was disposed of at the hospital.

Event Description

During an atrial fibrillation procedure, when mapping of the left atrium was being performed on the ensite, the catheter entered the left ventricle and became entangled in the chordae tendineae and the papillary muscles, and the catheter could not be removed from there.Torque was applied to the catheter by viewing through the echocardiogram, the catheter was pulled into the sheath, and pacing was applied with the catheter being moved, but the catheter could not be removed.The patient was moved to an operating room in the cardiovascular surgery unit and the catheter was removed by thoracoscopy and a valvuloplasty was performed for torn papillary muscles.It was found that the chordae tendineae and the papillary muscles were torn off and entangled.The catheter was disposed of at the hospital.There were no performance issues or damage to the catheter.

• 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: 11078388
• MDR Text Key: 223809768
• Report Number: 3005334138-2020-00607
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: D-AVSE-DF20-V1525
• Device Catalogue Number: D-AVSE-DF20-V1525
• Device Lot Number: 7379820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 86