NIAGARA

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 KINKS IN THE GUIDEWIRE WAS CONFIRMED BUT THE CAUSE IS UNKNOWN. A SINGLE PHOTOGRAPH OF COMPONENTS FROM A NIAGARA INSERTION KIT WAS RETURNED FOR EVALUATION. EVIDENCE OF USE WAS SEEN ON THE COMPONENTS, INCLUDING RESIDUAL FLUID ON THE COMPONENTS AND WITHIN THE LUMENS OF THE CATHETER. THE GUIDEWIRE CONTAINED TWO VISIBLE BENDS. THE BENDS APPEARED TO BE APPROXIMATELY NINETY-DEGREE ANGLES. NO OBVIOUS BREAKS OR ADDITIONAL DAMAGE WAS APPARENT ON THE SAMPLE. IT WAS REPORTED THAT THE GUIDEWIRE BECAME KINKED DURING THE PROCEDURE; HOWEVER, THE CIRCUMSTANCES WHICH LED TO THE DAMAGE ARE UNKNOWN. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPHS WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE FOR THE BENDS IN THE WIRE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

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.

Description of Event or Problem

IT WAS REPORTED, DURING THE USE OF A SHORT-TERM CATHETER, THE GUIDEWIRE BECAME KINKED AND COULD NOT BE ADVANCED. ULTIMATELY, ALL CATHETERS WERE REMOVED, AND THE PROCEDURE WAS RESTARTED WITH NEW CATHETERS. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.