ARTERIAL LINE KIT/1 20GA X 6"

Additional Manufacturer Narrative

A REVIEW OF THE DHR AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. ONE OPENED SAMPLE WAS RETURNED FOR REVIEW. THE CUSTOMER RETURNED ONLY A GUIDEWIRE AND DID NOT RETURN THE CATHETER FOR EVALUATION. THE WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION ACCORDING TO DWG-35-2803-XX, REV. B. WITHOUT THE CATHETER TO EVALUATE, THE RESULTS OF THE INVESTIGATION FOR THIS COMPLAINT ARE INCONCLUSIVE. A DEFINITE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED SINCE ALL THE SPECULATED COMPONENTS WERE NOT RETURNED TO COMPLETE A THOROUGH INVESTIGATION. SINCE THE INVESTIGATION RESULTS OF THIS COMPLAINT ARE INCONCLUSIVE, NO CORRECTIVE ACTION IS POSSIBLE. AT THIS TIME, THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THIS ISSUE WITH THIS PART NUMBER OR LOT NUMBER, HOWEVER, WE WILL CONTINUE TO MONITOR FOR ISSUES OF THIS NATURE IN THE FUTURE. ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11.

Description of Event or Problem

DURING INSERTION OF BRACHIAL ARTERIAL LINE, THE WIRE WOULD NOT FEED PAST THE HUB. UNSURE IF BLOCKAGE AT HUB OR THE WIRE TOO BIG TO PASS THROUGH HUB. I USED A SMALL WIRE TO NAVIGATE THE BLOCKAGE, AND THEN USING A CANNULA OVER THE SMALL WIRE, WAS THEN ABLE TO INSERT THE LINE. THIS APPROACH WAS USED BASED ON PREVIOUS SCENARIOS. IT IS NOT A DESIRABLE OR ELEGANT SOLUTION.

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.