CROSSER

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE 14S CROSSER CTO RECANALIZATION CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, IT WAS NOTED THE GUIDEWIRE PORT HAD A DETACHMENT AND NOT RETURNED. THE MARKER BAND WAS PRESENT. NO ANOMALIES WERE NOTED TO THE REST OF THE DEVICE. UPON MICROSCOPIC EVALUATION, THE BREAK OF THE GW PORT SHOWED A PORTION OF THE GW LUMEN PROTRUDING OUT OF THE PLASTIC OUTER CATHETER. NO FUNCTIONAL EVALUATION WAS PERFORMED AS THE ALLEGED FAILURE MODE WAS DETACHMENT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DETACHMENT AS THE GUIDEWIRE PORT WAS NOTED TO BE DETACHED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT 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. G3, H6 (DEVICE, COMPONENT, METHOD, RESULT, CONCLUSION). 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) 2025, A FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE WIRE PORT, THE VALVE WAS ALLEGEDLY COMPLETELY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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) 2025, A FEMALE PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, WHILE FLUSHING THE WIRE PORT, THE VALVE WAS ALLEGEDLY COMPLETELY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.