Multiple attempts have been made to get clarification on the specific device information, however no further information has been made available.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).There are 2 reports for this event: 2134070-2019-00122.
|
It was reported that a patient underwent a right atrial flutter procedure and a cardiac tamponade occurred.When attempting to place the reprocessed coronary sinus (cs) catheter, the device would cannulate the middle cardiac vein and would continually lose contact.The device was replaced to another reprocessed cs catheter, which also had difficulty being placed.After nearly 40 minutes of manipulation, the second cs catheter was able to be placed in the coronary sinus.The procedure was continued, and bidirectional block was successfully achieved.When manipulating the intracardiac echocardiogram catheter, a pericardial effusion was noted.Pericardiocentesis was performed to stabilize the patient.The physician believed the perforation was due to the coronary sinus catheters.Additionally, the physician has not said that there was a malfunction or issue with any of the devices that lead to the complication.The patient has since fully recovered without any need for additional medical intervention.
|