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 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 DURING THE USE OF THE SHORT TRANSLUMINAL CATHETER, THE OPENING OF THE PUNCTURE SHEATH CRACKED, PREVENTING NORMAL CATHETER ADVANCEMENT. AS A RESULT, CATHETER PLACEMENT COULD NOT BE COMPLETED. A NEW CATHETER SET WAS INITIATED TO SUCCESSFULLY ESTABLISH CATHETER PLACEMENT IN THE PATIENT. NO INJURY TO PATIENT.

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 DILATOR IS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE PHOTOGRAPH OF A DUALATOR DILATOR WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED THE DISTAL TIP OF THE DILATOR. THE TIP APPEARED WHITENED AND SLIGHTLY BENT OUTWARD. NO CRACKS OR SPLITS WERE OBSERVED IN THE TIP OF THE DILATOR. USE RESIDUE WAS OBSERVED ON THE SAMPLE. WHILE THE DILATOR WAS CONFIRMED TO BE DAMAGED, THE EXACT ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.