NIAGARA SLIM-CATH
Received Feb 24, 2026 · Event occurred Feb 10, 2026
Report 3006260740-2026-01125 · MDR key 24429709
Device
Generic name
Catheter, Hemodialysis, Implantable
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
5553240
Lot number
REJX2164
Product problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PUNCTURE SHEATH FAILED TO SUCCESSFULLY PENETRATE THE VESSEL DURING THE PROCEDURE. UPON REMOVAL, THE SHEATH TIP WAS FOUND SEVERELY DAMAGED, RENDERING IT UNUSABLE FOR ANOTHER ATTEMPT. A NEW CATHETER HAD TO BE INSERTED FOR THE CATHETERIZATION PUNCTURE. NO FURTHER DETAILS PROVIDED.
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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.
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 COMPLAINT OF DAMAGED VESSEL DILATOR TIP IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPHS OF A DUALATOR VESSEL DILATOR AND ONE PHOTOGRAPH OF DIALYSIS KIT LABELING WERE RETURNED FOR EVALUATION. VISUAL OBSERVATION OF THE FIRST PHOTOGRAPH SHOWS PACKAGING FOR THE NIAGARA SLIM-CATH DUAL LUMEN KIT. THE LOT#: REJX2164 AND REF#: (B)(4).CAN BE CONFIRMED FROM THE PHOTOGRAPH. VISUAL OBSERVATION OF THE SECOND PHOTOGRAPH SHOWS A DUALATOR VESSEL DILATOR. BLOOD RESIDUE CAN BE OBSERVED ON THE PROXIMAL END OF THE DILATOR IN THE PHOTOGRAPH. THE DISTAL TIP IS OBSERVED TO BE DEFORMED AND FRAYED. A SLIGHT TAPERING IN THE SHAFT OF THE DILATOR CAN ALSO BE OBSERVED IN THE PHOTOGRAPH. NO OTHER DAMAGE CAN BE DISCERNED FROM THE PHOTOGRAPH. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPHS OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.