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 STUCK GUIDEWIRE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE VIDEO OF A GUIDEWIRE AND AN 18G INTRODUCER NEEDLE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE VIDEO SHOWED A GUIDEWIRE INSERTED INTO AN 18G INTRODUCER NEEDLE. A SMALL PORTION OF THE DISTAL END OF THE GUIDEWIRE WAS OBSERVED TO BE PROTRUDING FROM THE DISTAL TIP OF THE INTRODUCER NEEDLE. A CLINICIAN ATTEMPTED TO ADVANCE AND RETRACT GUIDEWIRE, WHICH REVEALED THE GUIDEWIRE WAS STUCK WITHIN THE INTRODUCER NEEDLE. DURING ATTEMPTED RETRACTION, THE PROXIMAL END OF THE GUIDEWIRE WAS OBSERVED TO ELONGATE. BLOOD RESIDUE WAS OBSERVED ON THE GUIDEWIRE IN THE RETURNED VIDEO. WHILE THE GUIDEWIRE WAS CONFIRMED TO BE STUCK WITHIN THE INTRODUCER NEEDLE, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

Description of Event or Problem

IT WAS REPORTED THE GUIDE WIRE IS IRREVERSIBLY STUCK IN THE PUNCTURE NEEDLE. NO PATIENT INJURY WAS REPORTED. (B)(6) 2025- IT WAS FOUND DURING AN INVESTIGATION THE PROXIMAL END OF THE GUIDEWIRE WAS OBSERVED TO ELONGATE.