|
Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Vaso-Vagal Response (2661)
|
Event Date 07/18/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that during a cryo ablation procedure, the patient appeared to have a vasovagal response, and it was noted that the blood pressure declined.The freeze was aborted, and the patient's blood pressure continued to drop.The heart rate then slowed, then subsequently turned to ventricular fibrillation.Cardiopulmonary resuscitation and advanced cardiovascular life support (acls) protocol were then initiated, and the patient was defibrillated.It was noted that a brief episode of pulseless electrical activity (pea) was observed.A transthoracic echocardiogram was performed, and the case was aborted.The patient was under general anesthesia.The patient had an extended hospitalization, and the patient was reported to be stable.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Event summary: the patient data files showed at least two injections were performed with catheter 2af284/49774 on the date of the event without triggering of any system notice.The sheath was not returned for further investigation.Clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure.There is no sufficient evidence that the device potentially caused these adverse events.In conclusion, clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure.The sheath was not returned for further investigation.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|