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 STUCK GUIDEWIRE WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 18G INTRODUCER NEEDLE AND ONE NITINOL GUIDEWIRE. ADDITIONALLY, TWO PHOTOGRAPHS WERE ALSO SUBMITTED BY THE COMPLAINANT FOR REVIEW. NO ADDITIONAL INFORMATION WAS OBSERVED IN THE PHOTOGRAPHS WHICH CHANGED THE CONCLUSION OF THE INVESTIGATION. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE CAUSED BY RETRACTION OF THE GUIDEWIRE AGAINST THE BEVEL OF THE INTRODUCER NEEDLE. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND THE GUIDEWIRE WAS CONFIRMED TO BE BROKEN WHICH ALLOWED THE OUTER COIL WIRE TO BECOME UNRAVELED. MICROSCOPIC EXAMINATION OF THE FRACTURE SITES REVEALED THE FOLLOWING: NARROWING OF THE WIRE CROSS-SECTION NEAR THE FRACTURE SITE, WHICH IS A CHARACTERISTIC FEATURE OF A STRONG PULL ON THE WIRE. DAMAGE TO THE INSIDE EDGE OF THE INTRODUCER NEEDLE WHICH CAN OCCUR IF THE GUIDEWIRE IS FORCEFULLY RETRACTED AGAINST THE NEEDLE, DAMAGING THE SHAPE OF THE SHARPENED BEVEL. NORMAL MOVEMENT OF THE GUIDEWIRE IS AWAY FROM THE SHARPENED BEVEL AND WILL NOT DAMAGE THE WIRE. IF THE GUIDEWIRE DIRECTION IS REVERSED, THE GUIDEWIRE IS THEN PULLED AGAINST THE SHARPENED EDGE OF THE NEEDLE BEVEL AND CAN CAUSE SHEARING DAMAGE OF THE WIRE AND/OR CAUSE THE WIRE TO BECOME STUCK WITHIN THE NEEDLE. AN EXAMINATION OF THE WIRE STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT.

Description of Event or Problem

IT WAS REPORTED DURING A HEMODIALYSIS PROCEDURE AT THE HOSPITAL, A PHYSICIAN ATTEMPTED TO INSERT A SHORT-TERM CATHETER INTO A PATIENT. AFTER SUCCESSFUL PUNCTURE, THE GUIDEWIRE COULD NOT PASS THROUGH THE INTRODUCER NEEDLE. DESPITE MULTIPLE ADJUSTMENTS, THE WIRE REMAINED STUCK. ULTIMATELY, A BACKUP PRODUCT OF THE SAME MODEL WAS USED TO COMPLETE THE CATHETERIZATION.

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.