THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE: (B)(4). THIS EVENT WAS ALSO REPORTED BY THE MANUFACTURER IN MDR 2029046-2020-00273. REFERENCE: (B)(4).
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Patient 1
IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT A RIGHT SIDED ATRIAL FLUTTER (R-AFL) ABLATION PROCEDURE WITH A SOUNDSTAR? ECO DIAGNOSTIC ULTRASOUND CATHETER AND A WEBSTER ? CS CATHETER WITH EZ STEER? TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND RESULTED IN DEATH. WHEN THE DIAGNOSTIC PORTION OF THE PROCEDURE WAS COMPLETED (WHILE USING DIAGNOSTIC CATHETERS ONLY), THE PATIENT'S BLOOD PRESSURE DROPPED DRASTICALLY. THE SOUNDSTAR? ECO DIAGNOSTIC ULTRASOUND CATHETER WAS STILL INSIDE THE PATIENT'S BODY AND WAS USED TO CHECK FOR AN EFFUSION; HOWEVER, NO EFFUSION WAS CONFIRMED. THE ECHO TEAM WAS CALLED TO THE ROOM TO FURTHER EVALUATE THE POTENTIAL CAUSE OF THE DROP IN THE PATIENT'S BLOOD PRESSURE. THE PATIENT THEN WENT INTO CARDIAC ARREST. CODE WAS CALLED OVER HOSPITAL INTERCOM, AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AFTER APPROXIMATELY ONE HOUR, IT WAS ANNOUNCED THAT THE PATIENT HAD EXPIRED. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED, SINCE THE PATIENT WAS AN INPATIENT THAT HAD BEEN EXPERIENCING FLUTTER FOR AN EXTENDED PERIOD ALONG WITH OTHER MEDICAL CONDITIONS THAT WERE NOT SPECIFIED. NO ABLATION CATHETER WAS INSIDE THE PATIENT'S BODY AT THE TIME OF THE PATIENT'S DEATH. RADIO FREQUENCY (RF) WAS NOT DELIVERED. ON FEBRUARY 19, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE SOUNDSTAR? ECO DIAGNOSTIC ULTRASOUND CATHETER FOR EVALUATION, AND UPON INITIAL VISUAL INSPECTION, THERE WAS NO VISUAL DAMAGE OR ANOMALIES OBSERVED.