Description of Event or Problem · 0
EVENT SUMMARY: A PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VFIB) DURING A CORONARY IMAGING PROCEDURE, SHORTLY AFTER A MANUAL SALINE INJECTION (USING A SYRINGE) WAS ADMINISTERED TO CLEAR THE VESSEL OF BLOOD. THIS INJECTION WAS A STANDARD CLINICAL STEP PERFORMED UNDER PHYSICIAN CONTROL AND DISCRETION TO PREPARE THE VESSEL PRIOR TO IMAGING. IN THIS CASE THE PHYSICIAN CHOSE TO USE THE HYPERVUE IMAGING SYSTEM & STARLIGHT CATHETER. THE SALINE FLUSH WAS NOT CONTROLLED OR DELIVERED BY THE DEVICE, AND NOT PERFORMED AUTOMATICALLY BY ANY DEVICE FUNCTION. THE PATIENT WAS DEFIBRILLATED WHICH STABILIZED PATIENT'S HEART RHYTHM. A SUBSEQUENT PULLBACK USING A CONTRAST INJECTION AS THE FLUSH MEDIUM WAS COMPLETED. DEVICE INVOLVEMENT ASSESSMENT: FOLLOWING IS BASED ON EVENT INFORMATION REPORTED AND INITIAL INVESTIGATION OF THE EVENT DETAILS. · WHEN THE DEVICE WAS USED IT FUNCTIONED PER SPECIFICATIONS AND DID NOT MALFUNCTION. · THE ADVERSE EVENT OCCURRED IN THE CONTEXT OF A PHYSICIAN-CONTROLLED STEP AND WAS NOT DUE TO ANY MALFUNCTION, IMPROPER USE, INADEQUATE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. · THE EVENT IS CONSIDERED RELATED TO THE PROCEDURE, NOT THE DEVICE. NOTE: USE OF SALINE OR CONTRAST FOR VESSEL FLUSH FOR INTRAVASCULAR IMAGING IS DETERMINED BY THE PHYSICIAN, INCLUDING THE METHODOLOGY, VOLUME, AND FLOW OF INJECTION. INITIAL REPORTABILITY ASSESSMENT: THE INITIAL ASSESSMENT OF THIS EVENT DETERMINED THAT IT DOES NOT MEET THE CRITERIA FOR MANDATORY MEDICAL DEVICE REPORTING UNDER 21 CFR 803, AS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR DID IT MALFUNCTION IN A WAY THAT COULD LEAD TO SUCH AN OUTCOME. HOWEVER, IN THE INTEREST OF TRANSPARENCY, AND TO SUPPORT FDA'S POSTMARKET SURVEILLANCE EFFORTS, WE ARE VOLUNTARILY SUBMITTING THIS REPORT TO INFORM FDA OF THE EVENT AND OUR ONGOING MONITORING AND INVESTIGATION OF SIMILAR OCCURRENCES. NO CORRECTIVE OR PREVENTIVE ACTION IS CURRENTLY WARRANTED BASED ON THE INFORMATION AVAILABLE.