BIOSENSE WEBSTER INC QDOT MICRO¿ CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
|
Back to Search Results |
|
Catalog Number D139505 |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Cardiac Tamponade (2226)
|
Event Date 11/20/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
E1.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
|
|
Event Description
|
It was reported that a patient underwent a premature ventricular complex ablation procedure using a qdot micro¿ catheter.During ablation, the patient experienced cardiac tamponade that required pericardiocentesis and pericardial drain.After the mapping, the doctor inserted the qdot and went directly inside the coronary sinus (cs).The physician was told that they needed to do the zero for the force, but he said that the access to the cs was tough, so he did not want to get out.The physician stated that it would be fine without it.After a few ablation points in the cs, the patient showed a low tension.An echo confirmed the presence of a blood effusion inside the patient pericardium.A puncture through the sternum was required to remove the blood.Patient was hemodynamically stable.Patient fully recovered but needed an overnight hospital stay with a drain in order for the pericardium to empty fully.No evidence of steam pop.No error message indicated on carto or on the ngen generator.
|
|
Search Alerts/Recalls
|
|
|