SINGLE-LOOP SNARE RETRIEVAL KIT

Description of Event or Problem

CUSTOMER REPORTED, "RADIOPAQUE TIP BROKE OFF OF THE INTERMEDIATE CATHETER FOR THE SNARE. TIP LODGE IN THE HEART AND WAS UNABLE TO BE RETRIEVED. NO IDENTIFIED CONTRIBUTING FACTORS. DR. DENIED ANY USE OUTSIDE OF NORMAL PRACTICES. SLIGHT CURVED SHAPE WAS ADDED TO THE CATHETER FOR DIRECTION ABILITY BUT THIS IS NOT OUTSIDE OF NORMAL PRACTICES. NO IDENTIFIED CHANGES IN PRACTICES. USER WAS PROPERLY TRAINED. NO NOTED PATIENT PATHOLOGIES OR CONDITIONS THAT WOULD CONTRIBUTE TO TIP BREAKING OFF. PATIENT IS STABLE BUT WILL REQUIRE ADDITIONAL MONITORING. PER DR., PATIENT WILL HAVE ADDITIONAL X-RAY TODAY, IN ONE WEEK, AND IN 3 MONTHS TO MONITOR FOREIGN OBJECT."

Additional Manufacturer Narrative

THE SAMPLE WAS RETURNED TO ARGON FOR INVESTIGATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Additional Manufacturer Narrative

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 THE MANUFACTURER FROM THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED PRODUCT. THE VISUAL INSPECTION DETERMINED THAT THE DISTAL END OF THE INNER SHEATH DID NOT HAVE THE TUNGSTEN TIPS ATTACHED, SO THE COMPLAINT IN CONFIRMED. A FAILURE INVESTIGATION WAS INITIATED TO ADDRESS THE TIP DETACHMENT ISSUE. THE F.I. WILL DOCUMENT THE ROOT CAUSE IDENTIFIED AND THE CORRECTIVE ACTION THAT WAS TAKEN TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION PROVIDED IN H.3., H.6. AND H.11.