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	Injury (2348)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
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 incident device entrapment and catheter damage could not be conclusively determined.
Event or Problem 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 or Problem 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
• 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: 11078388
• Report Number: 3005334138-2020-00607
• Device Sequence Number: 1257324
• 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): 01/12/2021

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: 01/31/2023
• 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
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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: 46 YR
• Patient Weight: 86