CROSSER IQ ULTRASONIC

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: RECEIVED ONE CROSSER IQ ULTRASONIC CTO DEVICE. UPON VISUAL EVALUATION, MATERIAL DEFORMATION WAS OBSERVED TO THE CATHETER, PROXIMAL TO THE DISTAL TIP. THE MARKER BAND WAS PRESENT. UPON VISUALIZATION ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. MARKER BAND IS PRESENT AND HAD PEELING OVER IT. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. DAMAGE SUCH AS JAGGEDNESS WAS NOTED ON THE DISTAL END OF THE CATHETER SHEATH. THE DISTAL END OF THE GUIDEWIRE LUMEN WAS NOTED TO BE JAGGED AND SEPARATED FROM THE TIP. DUE TO THE ALLEGED COMPLAINT OF MATERIAL SEPARATION, NO FUNCTIONAL TESTING REQUIRED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING AS THE PEELING WAS NOTED ON THE MARKER BAND. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION AND IDENTIFIED PEELING 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. D4 (MEDICAL DEVICE EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #), E1, G3, H6 (DEVICE, 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 IN THE SUPERFICIAL FEMORAL ARTERY USING CROSSER DEVICE. DURING THE PROCEDURE, MID-DISTAL CHRONIC TOTAL OCCLUSION WAS FLUSHED AND REMOVED AND IT WAS FOUND THAT THE TIP HAD SHIFTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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 IN THE SUPERFICIAL FEMORAL ARTERY USING CROSSER DEVICE. DURING THE PROCEDURE, MID-DISTAL CHRONIC TOTAL OCCLUSION WAS FLUSHED AND REMOVED AND IT WAS FOUND THAT THE TIP HAD SHIFTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.