CROSSER

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 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) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE BY USING THE CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE TIP AND THE SHAFT ALLEGEDLY SEPARATED BUT STILL CONNECTED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

Additional Manufacturer Narrative

H11: 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 FOR EVALUATION. UPON VISUAL EVALUATION AND MICROSCOPIC VISUAL OBSERVATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. MARKER BAND IS PRESENT AND UNDAMAGED. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. DAMAGE WAS NOTED ON THE DISTAL END OF THE CATHETER SHEATH. THE INNER GUIDEWIRE LUMEN WAS NOT EXPOSED AND APPEARED TO BE ATTACHED TO THE CATHETER SHEATH. DUE TO THE RECEIVED CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING WAS PERFORMED. THE INVESTIGATION CONFIRMED THE REPORTED MATERIAL SEPARATION AS THE DISTAL TIP WAS SEEN SEPARATED FROM THE CATHETER. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AS DISTAL END OF CATHETER SHEATH WAS NOTED TO BE DAMAGED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION AND IDENTIFIED MATERIAL DEFORMATION 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, METHOD, RESULT, CONCLUSION) 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) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE BY USING THE CROSSER CATHETER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE TIP AND THE SHAFT ALLEGEDLY SEPARATED BUT STILL CONNECTED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.