ST. JUDE MEDICAL ADVISOR VL, SENSOR ENABLED CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|