NIAGARA SLIM-CATH

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 A BENT GUIDEWIRE WAS CONFIRMED BUT THE EXACT CAUSE IS UNDETERMINED. A SINGLE PHOTOGRAPH OF A GUIDEWIRE WAS RETURNED FOR EVALUATION. THE END OF THE GUIDEWIRE CONTAINED TWO SHARP BENDS WHICH APPEARED TO BE GREATER THAN 90° ANGLES. THE DISTAL WELD TIP OF THE GUIDEWIRE ALSO APPEARED TO BE BENT. NO OBVIOUS BREAKS OR ADDITIONAL DAMAGE WAS APPARENT ON THE SAMPLE. IT IS LIKELY 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 PHOTOGRAPH 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 GUIDE-WIRE BRANCH DURING SURGERY. NO OTHER DEVICES WERE USED DURING NORMAL OPERATION. NO PATIENT INJURY WAS REPORTED.