6F ANGIO-SEAL VIP ST. JUDE MEDICAL

NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES IN VERY THIN PTS THE COLLAGEN MAY PROTRUDE FROM THE SKIN AFTER TAMPING HAS BEEN COMPLETED. ATTEMPT TO PUSH THE COLLAGEN UNDER THE SKIN USING THE TAMPER TUBE OR A STERILE HEMOSTAT. DO NOT APPLY VIGOROUS TAMPING AS THIS MAY RESULT IN ANCHOR FRACTURE. DO NOT CUT OFF THE EXCESS COLLAGEN, AS THE SUTURE WOVEN THROUGH THE COLLAGEN MAY BE CUT AND THE INTEGRITY OF THE ANCHOR/COLLAGEN SANDWICH COULD BE COMPROMISED.

FOLLOWING A PERCUTANEOUS DIAGNOSTIC PROCEDURE, A 6F ANGIO-SEAL VIP WAS DEPLOYED. THE COLLAGEN REMAINED ABOVE THE SKIN FOLLOWING DEPLOYMENT. THE PHYSICIAN REPORTED THAT ATTEMPTS WERE MADE TO PLACE THE COLLAGEN UNDER THE SKIN UNSUCCESSFULLY, SO THE PT WAS HOSPITALIZED. IT WAS REPORTED A VASCULAR CONSULT WAS BEING CONSIDERED AS WELL AS ANTIBIOTIC TREATMENT. THE PT WAS AMBULATING AND WAS FEELING FINE. NO ADDITIONAL INFORMATION WAS RECEIVED INCLUDING IF ANY FURTHER INTERVENTION WAS PERFORMED.