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. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE 14S CROSSER CTO RECANALIZATION CATHETER. UPON VISUAL EVALUATION, MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. DAMAGE WAS NOTED ON THE DISTAL END OF THE CATHETER SHEATH SUCH AS A LONGITUDINAL BREAK AND JAGGED EDGES AROUND THE BREAK. THE BREAK ALLOWED FOR THE COREWIRE OF THE DISTAL TIP TO BE EXPOSED. THE MARKER BAND WAS NOT PRESENT AND NOT RETURNED. PROXIMAL TO THE DISTAL END WAS MATERIAL DEFORMATION ON THE CATHETER SHEATH WHERE THE CORE WIRE WAS EXPOSED AS WELL. THERE WAS A CIRCUMFERENTIAL CATHETER BREAK AT DISTAL END OF THE PLASTIC STRAIN RELIEF. WHITE RESIDUE INSIDE THE STRAIN RELIEF WAS NOTED TO BE SALINE. NO FUNCTIONAL TESTING WAS PERFORMED AS THE ALLEGED COMPLAINT WAS MATERIAL SEPARATION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED BETWEEN THE CATHETER SHAFT AND DISTAL TIP. AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK AS THE STRAIN RELIEF NOTED TO BE SEPARATED FROM THE SHAFT AND ALSO THE BREAK WAS NOTED IN THE CATHETER SHAFT WHERE THE CORE WIRE WAS EXPOSED. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL TORN AS THE CATHETER SHAFT WAS NOTE AT THE DISTAL END OF THE CATHETER. ALSO, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MARKER BAND DETACHMENT, AS THE MARKER BAND WAS NOTED TO BE DETACHED AND THE DETACHED PART WAS NOT RETURNED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION, IDENTIFIED BREAK, IDENTIFIED TORN AND IDENTIFIED MARKER BAND 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 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, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA CONTRALATERAL CFA USING THE CROSSER. DURING THE PROCEDURE, THE WIRE ALLEGEDLY COULD NOT BE PASSED THROUGH. IT WAS FURTHER REPORTED THAT THE TIP BROKE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: 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.

Description of Event or Problem

ON (B)(6) 2025, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA CONTRALATERAL CFA USING THE CROSSER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE WIRE ALLEGEDLY COULD NOT BE PASSED THROUGH. IT WAS FURTHER REPORTED THAT THE TIP BROKE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.