ATRIEVE VASCULAR SNARE KIT 7FR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11. EVALUATION SUMMARY: A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE RECORDED RELATING TO THIS ISSUE. ONE USED SAMPLE WAS RETURNED TO ARGON FROM THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE VISUAL INSPECTION DETERMINED THAT THERE WAS A PINHOLE AS WELL AS TWO ADDITIONAL INDENTATIONS IN A UNIFORM LINE ON THE DELIVERY CATHETER SHEATH. BECAUSE OF THE UNIFORMITY, IT IS SPECULATED THAT THE OBSERVED DAMAGE MAY HAVE BEEN CAUSED BY A TOOL OR MACHINERY. THE DELIVERY CATHETER SHEATH IS A PURCHASED PART SO, IT IS NOT KNOWN IF THE DAMAGE HAPPENED AT THE SUPPLIER OR DURING AN EVENT WITHIN THE USER'S ENVIRONMENT. SINCE A ROOT CAUSE CANNOT BE CONFIRMED, A CORRECTIVE ACTION CANNOT BE CONFIRMED. ARGON WILL CONTINUE TO MONITOR FOR RECURRENCE.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY.

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Description of Event or Problem

THE ATRIEVE WAS USED AT AFX PROCEDURE. AN AFX SHEATH WAS INSERTED FROM RIGHT FA AND PLACED IN THE TA. AND THEN THE DELIVERY CATHETER WITH THE SNARE WAS INSERTED FROM THE LEFT FA AND PLACED IN THE TA LIKEWISE. RIGHT AFTER THAT, BLOOD SPOUTED FROM THE SURFACE OF THE DELIVERY CATHETER. THE DEVICE WAS CHECKED AND NOTICED THAT THERE WAS A PINHOLE IN THE DELIVERY CATHETER AND BLOOD WAS SPOUTING FROM THERE. THE PIN HOLE LOCATED APPROX. 37 CM FROM THE DISTAL TIP OF CATHETER. THE PHYSICIAN DETERMINED THE LOCATION OF THE PIN HOLE DID NOT AFFECT ON THE PROCEDURE, THEREFORE, HE COVERED THE PINHOLE WITH A TAPING AND CONTINUED TO USE THE DEVICE. THE TAPING THAT WAS PUT TO COVER THE PINHOLE HAD BEEN REMOVED AT THE HOSPITAL BEFORE RETURNING THE DEVICE TO SUGAN.