Description of Event or Problem · 1
THE FOLLOWING NARRATIVE IS CONTAINED IN THE ORIGINAL MEDWATCH AND IS CORRECT AND FACTUAL. INITIAL CIRCUMSTANCES: ON (B)(6) 2012, (B)(6) MALE ARRIVES IN ED WITH CP. STEMI IDENTIFIED IN ED. EMERGENTLY TO CATH LAB. IDENTIFIED RCA TOTALLY OCCLUDED. THROMBECTOMY COMPLETED, UPON REMOVAL OF CATHETER, AIR WAS NOTICED IN A CORONARY ARTERY BY FILMS. SUBSEQUENT BRADYCARDIA, V-TACH, AND CARDIAC ARREST OCCURRED. PT INTUBATED AND INTERVENTIONALIST CONTINUED THE PROCEDURE DURING THIS TIME AND PLACED A DRUG ELUDING STENT. V-TACH CAN OCCUR FROM REPERFUSION OF THE RCA, AND FROM AIR. PT TO ICU, EXTUBATED, DOING WELL, DISCHARGED TO HOME WITHIN EXPECTED LOS 3 DAYS WITH STANDARD POST-STEMI/PTCA PLAN OF CARE. LATER DETERMINED (B)(6) 2013 THAT DEVICE USED DURING PROCEDURE WAS PART OF A RECALL BY THE FDA FOR POTENTIALLY ALLOWING AIR TO BE INTRODUCED DURING PROCEDURES. IN SUMMARY, THERE WAS AN FDA RECALL ON PRODUCT ISSUED (B)(6) 2013. DEVICE USED DURING PROCEDURE ON THIS PT ON (B)(6) 2012. THUS, IN FSH REVIEW OF EVENT, WITH INTRODUCTION OF AIR, WAS NOT SEEN AT THE TIME THAT DEVICE MAY HAVE BEEN FAULTY. IN HINDSIGHT AFTER REVIEWING FDA RECALL, IT WAS DECIDED TO SUBMIT THIS REPORT.