FREE-FLOW® TEMPORARY HEMODIALYSIS

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED. 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

DIALYSIS CATHETER WAS PLACED ACCORDING TO ROUTINE BY AN EXPERIENCED INSERTER. CONTROL X-RAY DONE WHERE THE CATHETER IS VISIBLE ON FOLLOW-UP EXAMINATION BUT NOT NOTED ON PRIMARY X-RAY. 6 DAYS LATER THE CATHETER IS SEEN ON ULTRASOUND EXAMINATION OF THE HEART. REMOVED ENDOVASCULARLY WITHOUT COMPLICATIONS.

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS PROVIDED. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED, ASSEMBLED, AND INSPECTED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE CONTRACT MANUFACTURER'S SUPPLIER ALSO CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION ALSO REVEALED THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. THEIR INVESTIGATION INCLUDED TESTS OF DEVICES FROM THE SAME LOT FOR CONNECTION FORCE, RUPTURE, AND BENDING. ALL WERE WITHIN SPECIFICATION. WITHOUT AN EVALUATION OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED BUT IS NOT LIKELY MANUFACTURING RELATED. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING WARNINGS: DO NOT ADVANCE THE GUIDEWIRE OR CATHETER IF UNUSUAL RESISTANCE IS ENCOUNTERED. DO NOT INSERT OR WITHDRAW THE GUIDEWIRE FORCIBLY FROM ANY COMPONENT. THE WIRE MAY BREAK OR UNRAVEL. IF THE GUIDEWIRE BECOMES DAMAGED, THE CATHETER AND GUIDEWIRE MUST BE REMOVED TOGETHER. WHEN INTRODUCER NEEDLE IS USED, DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO AVOID POSSIBLE SEVERING OF GUIDEWIRE. INSUFFICIENT TISSUE DILATION CAN CAUSE COMPRESSION OF THE CATHETER LUMEN AGAINST THE GUIDEWIRE CAUSING DIFFICULTY IN THE INSERTION AND REMOVAL OF THE GUIDEWIRE FROM THE CATHETER. THIS CAN LEAD TO BENDING OF THE GUIDEWIRE. 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.