CROSSER

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO PASS THROUGH THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DAMAGED NEAR THE TIP. 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. 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 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.

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: RECEIVED ONE 14S CROSSER CTO RECANALIZATION CATHETER. UPON VISUAL INSPECTION, IT WAS NOTED THERE WAS MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND CATHETER SHEATH; DISTAL END OF CATHETER SHEATH APPEARS JAGGED. PEELING WAS PRESENT OVER THE MARKER BAND. NO ANOMALIES NOTED TO THE TRANSDUCER HANDLE OR SONIC CONNECTOR. DUE TO THE CONDITION OF MATERIAL SEPARATION PRESENT ON THE DISTAL TIP, NO FUNCTIONAL TESTING REQUIRED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE AS THE CONDITIONS FOR USE COULD NOT BE REPLICATED IN THE LABORATORY. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING AS THE PEELING WAS PRESENT OVER THE MARKER BAND AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AS THE DISTAL END OF CATHETER SHEATH APPEARS JAGGED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE, MATERIAL SEPARATION AND IDENTIFIED MATERIAL DEFORMATION AND PEELING COULD NOT BE DETERMINED BASED ON 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 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.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO PASS THROUGH THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DAMAGED NEAR THE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.