CROSSER

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER TO TREAT CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH. DURING THE PROCEDURE, THE TIP EXTENSION WAS CHECKED AND REMOVED DUE TO THE RISK OF DETACHMENT. REPORTEDLY, IT WAS CONFIRMED THAT THE ABNORMALITY OF THE TIP WHEN THE CATHETER WAS NOT IN USE BY PUSHING IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE 14S CROSSER CTO RECANALIZATION CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, IT WAS NOTICED THE TIP IS DISPLACED AND NOT SEATED CORRECTLY ON THE CATHETER SHEATH. IT IS NOTED IT IS NOT COMPLETELY SEPARATED BUT NOT ALIGNED WITH THE SHEATH. THERE WAS DRIED SALINE RIGHT BELOW THE TIP AND DISTAL TO THE MARKER BAND. MARKER BAND WAS PRESENT AND UNDAMAGED. NO ANOMALIES NOTED TO THE REST OF THE CATHETER. NO FUNCTIONAL TESTING WAS PERFORMED AS THE ALLEGED FAILURE WAS SEPARATION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE PARTIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND SHAFT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION 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 (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 PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER TO TREAT CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH. DURING THE PROCEDURE, THE TIP EXTENSION WAS CHECKED AND REMOVED DUE TO THE RISK OF DETACHMENT. REPORTEDLY, IT WAS CONFIRMED THAT THE ABNORMALITY OF THE TIP WHEN THE CATHETER WAS NOT IN USE BY PUSHING IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.