6F ANGIO-SEAL VIP DEVICE ST. JUDE MEDICAL, INC

NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER THAT ERRATIC, VIGOROUS TAMPING OR EXCESSIVE UPWARD TENSION ON THE SUTURE MAY RESULT IN COLLAGEN PLACEMENT IN THE ARTERY OR ANCHOR BREAKAGE. THE IFU CAUTIONS IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR PT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

IT WAS REPORTED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. SOMETIME AFTER DEPLOYMENT, THE PT EXPERIENCED DIFFICULTIES WHICH REQUIRED SURGICAL INTERVENTION. THE ANCHOR AND SUTURE WERE REMOVED FROM THE PT'S KNEE AREA. THE PT'S CONDITION WAS REPORTED TO BE OKAY. THE PHYSICIAN REPORTING THE INCIDENT WAS NOT THE DEPLOYING PHYSICIAN. LIMITED INFO WAS PROVIDED AND ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.