NIAGARA SLIMCATH

Additional Manufacturer Narrative

H11: SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS.

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2025 PULMONARY EDEMA PATIENT WITH AN AIR LEAK MANIFESTED WHILE USING AN INDWELLING FEMORAL VEIN DIALYSIS CATHETER. A LEFT FEMORAL VEIN WAS PLACED AND WAS FOUND TO BE LEAKING SIGNIFICANTLY RESULTING IN THE NEED FOR AN ADDITIONAL SEPARATE PUNCTURE KIT TO BE REMOVED. THIS RESULTED IN REPEATED PUNCTURES AND SIGNIFICANTLY LONGER PUNCTURE TIME, WHICH WAS NOT TOLERATED BY THE PATIENT.