BETA-CATH SYSTEM

Additional Manufacturer Narrative

INITIAL FINDINGS INDICATE THAT THERE WAS NO SERIOUS INJURY THAT WOULD BE IDENTIFIED AS LIFE-THREATENING, RESULTING IN PERMANENT IMPAIRMENT OF A BODY FUNCTION, DAMAGE TO A BODY STRUCTURE, OR REQUIRING MEDICAL OR SURGICAL INTERVENTION. TREATMENT WAS DELIVERED WITH NO OVEREXPOSURE OR UNDUE DELAY. THERE IS NO INDICATION THAT ACTION WOULD BE REQUIRED TO REDUCE RISK TO PUBLIC HEALTH. EXAMINATION OF THE COMPLAINT DEVICE INDICATES THAT THE TIP BOND DID NOT FAIL AND THAT THE SEPARATION OF PART OF THE TIMP MATERIAL WAS MOST LIKELY THE RESULT OF DAMAGE CAUSED BY INTERACTION WITH CONCOMITANT DEVICES AND/OR TORTUOUS ANATOMY DURING THE PROCEDURE. A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY TREND THAT MIGHT REPRESENT A THREAT TO HUMAN HEALTH. THERE WERE NO NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THIS LOT. ALL PRODUCTION PARAMETERS AND ACCEPTANCE REQUIREMENTS WERE MET AND RECORDED. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED.

Description of Event or Problem

USER REPORTED THAT RADIOACTIVE SOURCE TRAIN WAS STUCK IN CATHETER AND SYSTEM WAS MANUALLY REMOVED. PATIENT WAS SUCCESSFULLY TREATED WITH A SECOND DEVICE. DURING SUBSEQUENT ON-SITE EXAMINATION BY A MANUFACTURING REPRESENTATIVE THE NEXT DAY, IT WAS NOTED THAT THE TIP WAS DEFORMED AND A FRACTION OF THE TIMP MATERIAL HAD BEEN SCRAPED OFF. THE COMPANY REPRESENTATIVE IMMEDIATELY INFORMED THE SITE STAFF. A REVIEW OF FLUOROSCOPIC FILMS INDICATED THAT THE MATERIAL MIGHT BE INSIDE THE PATIENT, DISTAL TO THE TREATMENT ZONE.