Description of Event or Problem · 0
THIS LETTER IS TO INFORM YOU OF THIS ADVERSE EVENT AS THE SUSPECTED DEVICE OF THE OSCOR GUIDSTAR SHEATH IS NOT MANUFACTURED OR IMPORTED BY BIOSENSE WEBSTER, INC. EVENT DESCRIPTION: ON (B)(6) 2020 PROBABLY DURING PROCEDURE THE PATIENT PRESENTED WITH TRANSIENT ELEVATED ST SEGMENT. INTERVENTION WAS UNSPECIFIED MEDICATION. ACCORDING TO THE PRINCIPAL INVESTIGATOR, THIS EVENT WAS MODERATE IN SEVERITY, NOT SERIOUS, NOT RELATED TO STUDY DEVICE , NOT RELATED TO STUDY PROCEDURE, NOT RELATED TO COOLFLOW SALINE IRRIGATION PUMP), AND POSSIBLY RELATED TO OSCOR GUIDSTAR SHEATH WHICH IS A SHEATH USED FOR THE STELLAR IDE PROTOCOL, BUT NOT THE OBJECT OF THE INVESTIGATION. NO SOURCE MATERIALS WERE PROVIDED. PHYSICIANS BELIEVED THAT IT COULD BE ONLY MECHANICAL INJURY, NO EVIDENCE TO EXCLUDE OR CONFIRM AIR EMBOLISM AS FAR AS WE KNOW. THE OSCOR GUIDSTAR WAS IRRIGATED WITH SMARTABLATE PUMP, 2ML/MIN. THERE WAS NO EVIDENCE OF AIR EMBOLISM RELATED TO THE COOLFLOW PUMP, NO BUBBLE SIGNALED BY CALIBRATED PUMP AND TUBING WELL INSPECTED BEFORE ENTERING THE DEVICE INTO THE OSCOR GUIDESTAR. BASED ON THIS INFORMATION, THIS EVENT IS UNRELATED TO ANY MARKETED BIOSENSE WEBSTER DEVICE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).