BIOSENTRY®

Additional Manufacturer Narrative

THIS EVENT WAS IDENTIFIED DURING INTERNAL QUALITY SYSTEM ACTIVITIES. UPON REVIEW, THE MANUFACTURER DETERMINED THE EVENT MEETS FDA CRITERIA FOR REPORTING. THE REPORT IS BEING SUBMITTED TO ENSURE ACCURACY AND COMPLETENESS OF MDR FILES. THIS SUBMISSION DOES NOT REFLECT A CHANGE IN DEVICE PERFORMANCE OR PATIENT RISK. THE AWARENESS DATE CORRESPONDS TO WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT DETAILS. ALL INFORMATION REASONABLY KNOWN TO THE MANUFACTURER AT THIS TIME HAS BEEN INCLUDED. THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THIS COMPLAINT WILL BE USED TO TREND FOR SIMILAR COMPLAINTS. THE COMPLAINT WAS CONFIRMED, HOWEVER THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

THE CUSTOMER REPORTS THE PHYSICIAN HAD FINISHED TAKING ALL BIOPSY SAMPLES AND THEY WERE READY TO DEPLOY THE BIOSENTRY PLUG. THEY NOTICED THE PATIENT ALREADY HAD A PNEUMO SO THEY WERE READY TO DEPLOY THE PLUG AND FINISH THE CASE. THEY OPENED UP ONE BIOSENTRY PLUG AND NOTICED THE PUSHER WOULD NOT ADVANCE THROUGH THE ADAPTOR SO IT COULD NOT DEPLOY. THEY OPENED UP ANOTHER BIOSENTRY PLUG OF THE SAME LOT, BUT NOTICED THIS ONE WAS NOT ABLE TO ADVANCE ALL THE WAY THROUGH THE ADAPTOR EITHER. AT THIS POINT THEY OPENED UP AN OLDER LOT THEY HAD ON HAND TO COMPLETE THE PROCEDURE. THE PATIENT ALSO REQUIRED A BLOOD PATCH. NO ADDITIONAL DETAILS PROVIDED.