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 IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING MATERIAL 5553150, THE GUIDEWIRE CANNOT BE PULLED OUT. NO FURTHER INFORMATION 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 A DAMAGED GUIDEWIRE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE VIDEO OF A GUIDEWIRE AND INTRODUCER NEEDLE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE VIDEO SHOWED THE CLINICIAN UNABLE TO ADVANCE OR WITHDRAW THE GUIDEWIRE WITHIN THE NEEDLE. DURING THE ATTEMPTED WITHDRAWALS OF THE GUIDEWIRE, THE GUIDEWIRE APPEARED TO BE STRETCHING/ELONGATING WHICH INDICATED THE CORE WIRE WAS LIKELY BROKEN. A SPECIFIC ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED BASED ON THE RETURNED VIDEO. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED VIDEO OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.