NIAGARA SLIMCATH

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 BROKEN GUIDEWIRE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE VIDEO OF A J TIP GUIDEWIRE WAS RETURNED FOR EVALUATION. THE VIDEO SHOWED THE CLINICIAN PULLING BACK ON THE GUIDEWIRE, AND THE GUIDEWIRE WAS OBSERVED TO STRETCH. THIS LIKELY INDICATES A BREAK OF THE CORE WIRE. A SMALL PORTION OF THE GUIDEWIRE TIP WAS OBSERVED PROTRUDING FROM THE NEEDLE BEVEL. THE CLINICIAN THEN GRASPED THE GUIDEWIRE TIP WITH HEMOSTATS TO PULL THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE, AND THE GUIDEWIRE WAS OBSERVED TO STRETCH AGAIN. USE RESIDUE WAS OBSERVED ON THE SAMPLE IN THE RETURNED VIDEO. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED VIDEOS OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. 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 THAT PULLING OF THE GUIDEWIRE WITH LOTS OF STRETCHING; THE CLINICIAN SEEMS TO UNRAVEL THE COIL AT THE END.