NIAGARA SLIMCATH, PC CATHETER SHAFT

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. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT DELIVERY OF GUIDE WIRE FOUND TO BE DAMAGED AND UNUSABLE, RESOLVED BY REPLACING WITH NEW SET.

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 PHOTOGRAPH OF A GUIDEWIRE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED A PORTION OF THE GUIDEWIRE INSERTED THROUGH THE PINK HUB OF AN INTRODUCER NEEDLE. THE CORE WIRE WAS OBSERVED TO BE BROKEN AND THE COIL WIRE WAS SLIGHTLY ELONGATED. THE BROKEN CORE WIRE WAS PROTRUDING OUT OF THE COIL WIRE. NO DETAILS OF THE FRACTURE COULD BE DISCERNED IN THE RETURNED PHOTOGRAPH. THE PROXIMAL AND DISTAL ENDS OF THE GUIDEWIRE WERE NOT OBSERVED IN THE RETURNED PHOTOGRAPH. WHAT APPEARED TO BE USE RESIDUE WAS OBSERVED ON THE HUB OF THE INTRODUCER NEEDLE. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPH OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE OF THE BREAK. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.