CROSSER

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. H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE CROSSER 14S CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES WERE NOTED TO THE TRANSDUCER HANDLE AND SALINE HUB. MARKER BAND IS PRESENT AND UNDAMAGED. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHAFT. NO FUNCTIONAL EVALUATION WAS PERFORMED DUE TO THE MATERIAL SEPARATION IN THE DISTAL PORTION OF THE CATHETER. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED BETWEEN THE CATHETER SHAFT AND DISTAL TIP. 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 (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 PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER DEVICE. PRIOR TO THE PROCEDURE, THE TIP AND CATHETER WERE MISALIGNED DURING SETUP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER DEVICE. PRIOR TO THE PROCEDURE, THE TIP AND CATHETER WERE MISALIGNED DURING SETUP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT

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. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 PROVIDED 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.