CROSSER

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: RECEIVED ONE 14S CROSSER CTO RECANALIZATION CATHETER FOR EVALUATION. SEPARATION AND DEFORMATION WERE OBSERVED DISTAL TO THE STRAIN RELIEF, WITH THE CORE WIRE EXPOSED AT THE SEPARATION SITE. VISUAL AND MICROSCOPIC EVALUATION IDENTIFIED NO ANOMALIES WITH THE TRANSDUCER HANDLE OR SALINE HUB. A PARTIAL CIRCUMFERENTIAL BREAK WAS OBSERVED BETWEEN THE PROXIMAL CATHETER SHAFT AND THE STRAIN RELIEF. THE MARKER BAND WAS PRESENT AND UNDAMAGED. DURING FUNCTIONAL TESTING, THE DEVICE WAS SUCCESSFULLY CONNECTED TO THE CROSSER GENERATOR AND ACTIVATED WITHOUT ISSUE. MINOR WATER LEAKAGE WAS OBSERVED AT THE STRAIN RELIEF, WHILE NO FLUID WAS OBSERVED EXITING THE DISTAL TIP. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED LEAK AT THE STRAIN RELIEF, AND THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED CONNECT PROBLEM AS THE DEVICE WAS SUCCESSFULLY CONNECTED TO THE CROSSER GENERATOR AND ACTIVATED WITHOUT ANY ISSUES. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK BETWEEN PROXIMAL CATHETER SHAFT AND THE STRAIN RELIEF AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AT THE DISTAL TO THE STRAIN RELIEF. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK, CONNECTION PROBLEM, IDENTIFIED BREAK AND MATERIAL DEFORMATION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. PRIOR TO THE PROCEDURE, LEAK WAS IDENTIFIED AT THE BASE OF THE CATHETER SHAFT. FURTHER IT WAS REPORTED THAT THE CONSOLE DID NOT RESPOND. THERE WAS NO PATIENT CONTACT.