ATRIEVE VASCULAR SNARE KIT 6FR

Description of Event or Problem

DURING THE PRE-TEST THE FUNCTION OF THE ATRIEVE¿ VASCULAR SNARE IS OK, BUT WHEN THE OPERATORS WERE PUTTING THE ATRIEVE¿ VASCULAR SNARE IN THE VESSEL THEY FOUND THE COIL WAS KEEPING FALLING FROM THE LOOP, SO THE OPERATOR JUST IMMEDIATELY TOOK THE ATRIEVE¿ VASCULAR SNARE OUT. BECAUSE THIS PATIENT'S CONDITION IS UNSTABLE AND VERY BAD, SO THEY COULDN'T CONTINUOUS USE ANOTHER NEW VASCULAR SNARE TO TAKE THOSE FALLING COILS OUT. THE PHYSICIAN IS VERY UPSET ABOUT THE FALLING COILS. PLEASE NOTED THE FALLING COILS ARE STILL LEFT IN THIS PATIENT'S VESSEL NOW.

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

Additional Manufacturer Narrative

THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

Description of Event or Problem

DURING THE PRE-TEST THE FUNCTION OF THE ATRIEVE¿ VASCULAR SNARE IS OK, BUT WHEN THE OPERATORS WERE PUTTING THE ATRIEVE¿ VASCULAR SNARE IN THE VESSEL THEY FOUND THE COIL WAS KEEPING FALLING FROM THE LOOP, SO THE OPERATOR JUST IMMEDIATELY TOOK THE ATRIEVE¿ VASCULAR SNARE OUT. BECAUSE THIS PATIENT'S CONDITION IS UNSTABLE AND VERY BAD, SO THEY COULDN'T CONTINUOUS USE ANOTHER NEW VASCULAR SNARE TO TAKE THOSE FALLING COILS OUT. THE PHYSICIAN IS VERY UPSET ABOUT THE FALLING COILS. PLEASE NOTED THE FALLING COILS ARE STILL LEFT IN THIS PATIENT'S VESSEL NOW.

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. ONE USED ATRIEVE WAS RETURNED TO ARGON FROM THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE VISUAL INSPECTION ESTABLISHED THAT THE NITINOL WIRE WAS BUNCHED UP IN BUNDLES AT THE ENDS OF THE LOOPS. UPON CLOSER LOOK, IT SEEMS THAT THE NITINOL WIRE WAS BROKEN NEAR THE BASE. THE DAMAGE LOOKS CONSISTENT WITH THE SNARE BEING PULLED USING EXCESSIVE FORCE DURING RETRIEVAL. THE COMPLAINT DESCRIPTION MENTIONS THAT THE SNARE LOOKED OKAY PRIOR TO USE, SO IT IS LIKELY THAT THE DAMAGE HAPPENED AS A RESULT OF AN EVENT WITHIN THE USER'S ENVIRONMENT AND NOT A MANUFACTURING ISSUE. SINCE THE DAMAGE IS LIKELY TO HAPPEN AS A RESULT OF AN EVENT WITHIN THE USER'S ENVIRONMENT, NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME.

Description of Event or Problem

DURING THE PRE-TEST THE FUNCTION OF THE ATRIEVE¿ VASCULAR SNARE IS OK, BUT WHEN THE OPERATORS WERE PUTTING THE ATRIEVE¿ VASCULAR SNARE IN THE VESSEL THEY FOUND THE COIL WAS KEEPING FALLING FROM THE LOOP, SO THE OPERATOR JUST IMMEDIATELY TOOK THE ATRIEVE¿ VASCULAR SNARE OUT. BECAUSE THIS PATIENT'S CONDITION IS UNSTABLE AND VERY BAD, SO THEY COULDN'T CONTINUOUS USE ANOTHER NEW VASCULAR SNARE TO TAKE THOSE FALLING COILS OUT. THE PHYSICIAN IS VERY UPSET ABOUT THE FALLING COILS. PLEASE NOTED THE FALLING COILS ARE STILL LEFT IN THIS PATIENT'S VESSEL NOW.