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 A DAMAGED GUIDEWIRE WAS CONFIRMED BUT THE ROOT CAUSE COULD NOT BE DETERMINED. ONE PHOTOGRAPH OF A GUIDEWIRE WAS RETURNED FOR EVALUATION. INSPECTION OF THE PHOTOGRAPH FOUND THAT ONLY A PORTION OF THE GUIDEWIRE WAS VISIBLE SUCH THAT BOTH ENDS OF THE WIRE WERE NOT IN THE FRAME OF THE PHOTO. THE GUIDEWIRE CAN BE SEEN BEING HELD IN A LOOP, AND A KINK CAN BE SEEN ON THE GUIDEWIRE NEAR THE APEX OF THE LOOP. NO OTHER DAMAGE IS VISIBLE THROUGHOUT THE GUIDEWIRE AND THERE IS NO INDICATION THAT THE LENGTH OF THE GUIDEWIRE HAS BEEN ALTERED. BASED ON THE MATERIAL FOR REVIEW, A KINK WAS CONFIRMED BUT THERE WERE NO DISTINGUISHING FEATURES IN THE PHOTOGRAPHS OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE OF THE KINK. THEREFORE, THE ROOT CAUSE REMAINS UNKNOWN. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

Description of Event or Problem

IT WAS REPORTED, TWO CONSECUTIVE CASES OF GUIDEWIRES WERE FOUND TO BE SHORT, FLEXIBLE, AND PRONE TO KINK, AND COULD NOT BE RETRIEVED SMOOTHLY FROM THE INTRODUCER NEEDLE. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS 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.