HEMO-CATH® ST SILICONE DOUBLE LUMEN CATHETER

Additional Manufacturer Narrative

THE 13.5F SILICONE DOUBLE LUMEN CATHETER WAS RETURNED FOR EVALUATION WITH THE EXTENSION CLAMPS CLOSED. FUNCTIONAL TESTING, FLUSHING THE DEVICE, WAS ATTEMPTED BY CLAMPING THE DISTAL END OF THE LUMEN WITH HEMOSTATS AND FLUSHING THE DEVICE THROUGH EACH OF THE LUERS. THIS WAS UNSUCCESSFUL DUE TO THE EXTENSION TUBING BEING CRIMPED SHUT UNDER THE CLAMPS. THE DEVICE WAS NOT RETURNED FOR 2 MONTHS AFTER THE EVENT WAS REPORTED. IT IS UNKNOWN IF THIS OCCURRED DURING USE OR IF THE CRIMPING OF THE SILICONE EXTENSION TUBING OCCURRED DUE TO BEING CONTINUOUSLY CLAMPED FOR MORE THAN 2 MONTHS. VISUAL EXAMINATION OF THE CATHETER LUMEN INDICATED THAT WHEN THE CATHETER LUMEN IS BENT, A SMALL HOLE IS VISIBLE JUST BELOW THE HUB. UNDER MAGNIFICATION IT APPEARS THAT THE HOLE IS THE RESULT OF AN EXTERNAL SLICE CREATED BY A SHARP INSTRUMENT SUCH AS A SCALPEL OR SCISSORS. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT NUMBER PROVIDED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE MANUFACTURING PROCESS INCLUDES A 100% LEAK TEST PERFORMED AS A LAST STEP IN THE PROCESS. THIS TEST WOULD HAVE DETECTED ANY LEAKS, HOLES, OR WEAK SPOTS IF IT HAD EXISTED AT THE TIME OF MANUFACTURE. THE CATHETER WAS IMPLANTED FOR 3 WEEKS PRIOR TO THE DAMAGE BEING DETECTED. THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE.

Additional Manufacturer Narrative

WE ARE CURRENTLY WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

A FEW TIMES AFTER THE CONNECTION WITH THE PATIENT FOR HIS DIALYSIS TREATMENT, BLEEDING FROM THE CATHETER LED THE NURSE TO OBSERVE A VISIBLE CRACK ON THE CATHETER (LUMEN).