IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PROCEDURE AN ANGIO-SEAL WAS USED AT THE RIGHT FEMORAL ARTERIOTOMY. LATER THAT NIGHT, THE PATIENT'S LEG BECAME COLD AND THE PATIENT WAS BROUGHT BACK TO THE INTERVENTIONAL RADIOLOGY LAB. THE ANGIOGRAM REVEALED A RIGHT LEG OCCLUSION AT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SOMETHING WAS SEEN FLOPPING AT THE DEPLOYMENT SITE AND ATTEMPTS WERE MADE TO SNARE IT. THIS WAS UNSUCCESSFUL AND THE PHYSICIAN ALLEGED THAT HE MAY HAVE PUSHED IT DOWN THE LEG FURTHER. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO RESTORE BLOOD FLOW TO THE LEG. ADDITIONAL INFORMATION REVEALED THAT THERE WAS A PIECE OF CALCIUM DISLODGED THAT CAUSED THE EVENT. NO FURTHER DETAILS WERE AVAILABLE AT THIS TIME.
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Patient 1
NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PATIENT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5MM OF THE PUNCTURE SITE. THE IFU ALSO INSTRUCT THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THERE WAS NO ANGIO-SEAL TRAINING RECORD FOUND FOR THIS PHYSICIAN. THE IFU CAUTIONS THAT THE ANGIO-SEAL DEVICE IS TO BE USED ONLY BY A LICENSED PHYSICIAN (OR OTHER HEALTH CARE PROFESSIONAL AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIAN) POSSESSING ADEQUATE INSTRUCTION IN THE USE OF THE DEVICE, E.G., PARTICIPATION IN AN ANGIO-SEAL PHYSICIAN INSTRUCTION PROGRAM OR EQUIVALENT.