Description of Event or Problem · 0
IT WAS REPORTED THAT AT THE END OF THE CASE WHILE THE PHYSICIAN WAS CLOSING UP USING A PERCLOSE VASCULATURE CLOSURE DEVICE, THE J WIRE BECAME STUCK IN THE VASCULATURE. THE CALLER REPORTED THAT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE J WIRE. THE J WIRE WAS NOT A PART OF A BIOSENSE WEBSTER, INC. DEVICE. THE CALLER REPORTED THAT SHE WAS UNSURE IF THE J WIRE WAS A PART OF THE CLOSURE DEVICE. THE PHYSICIAN CONSULTED WITH VASCULAR. THE CALLER REPORTED THAT IT WAS UNKNOWN IF ANY FURTHER MEDICAL INTERVENTION WAS PROVIDED AT THE TIME OF THE CALL. THE LAST KNOWN PATIENT STATUS WAS STABLE. THE THERAPEUTIC/DIAGNOSTIC BWI PRODUCT IN USE WAS AN OCTARAY CATHETER. THE CARTO 3 SYSTEM WAS USED FOR MAPPING AND THE FARAPULSE SYSTEM WAS USED FOR ABLATION. THE PETAL XML WAS USED. THE NGEN SYSTEM WAS POWERED ON BUT NOT USED. ADDITIONAL INFORMATION PROVIDED. THE WIRE WAS SNARED FROM THE IJ BY INTERVENTIONAL CARDIOLOGY. NO FURTHER INJURIES OCCURRED AND THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS FROM THIS. PATIENT IS FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).