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 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 DURING THE PLACEMENT OF CATHETER ENCOUNTERED AN ISSUE WHERE THE GUIDEWIRE BECAME STUCK AFTER PARTIAL INSERTION INTO THE INTRODUCER NEEDLE. DESPITE MULTIPLE ATTEMPTS, THE GUIDEWIRE COULD NOT BE ADVANCED FURTHER. ULTIMATELY, A BACKUP PRODUCT OF THE SAME MODEL WAS USED TO COMPLETE THE CATHETERIZATION. NO FURTHER DETAILS WERE 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 COMPLAINT OF FRAYED GUIDEWIRE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF AN 18 G INTRODUCER NEEDLE, ONE PHOTOGRAPH OF A GUIDEWIRE, AND ONE PHOTOGRAPH OF A PRODUCT LABEL WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE FIRST PHOTOGRAPH SHOWED AN 18 G INTRODUCER NEEDLE. BLOOD RESIDUE WAS OBSERVED ON THE INTRODUCER NEEDLE. NO DAMAGE WAS VISIBLE ON THE INTRODUCER NEEDLE. AN INITIAL VISUAL OBSERVATION OF THE SECOND PHOTOGRAPH SHOWED A GUIDEWIRE THAT WAS OBSERVED TO BE ELONGATED WITH LARGE SPACING IN BETWEEN THE COILS. THIS DAMAGE INDICATES THAT THE CORE WIRE WAS BROKEN. AN INITIAL VISUAL OBSERVATION OF THE THIRD PHOTOGRAPH SHOWED A PRODUCT LABEL WITH THE CORRESPONDING BATCH NUMBER. (REKQ2565) THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPHS OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.