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 FOR EVALUATION. UPON VISUAL INSPECTION, BREAK WAS OBSERVED AT THE GUIDEWIRE PORT, ALONG WITH MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND CATHETER SHEATH. THE MARKER BAND WAS PRESENT, AND SLIGHT DAMAGE WAS NOTED AT THE DISTAL END OF THE CATHETER SHEATH; HOWEVER, THE INNER GUIDEWIRE LUMEN WAS NOT EXPOSED. FUNCTIONAL TESTING USING AN IN-HOUSE GUIDEWIRE DEMONSTRATED SMOOTH ADVANCEMENT AND RETRACTION WITHOUT RESISTANCE WHEN INSERTED FROM BOTH THE DISTAL TIP AND THE FRACTURED GUIDEWIRE PORT, EXITING THROUGH THE ALTERNATE END IN EACH CASE. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED INCOMPATIBILITY ISSUE AS FUNCTIONAL TESTING COULD NOT BE PERFORMED BY INSERTING THE GUIDEWIRE INTO THE DISTAL TIP. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK WAS OBSERVED TO THE GUIDEWIRE PORT. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND CATHETER SHEATH AND ALSO THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AT DISTAL END OF THE CATHETER SHEATH. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED IMPROPER OR INCORRECT PROCEDURAL METHOD AS THE USER PERFORMED THE PROCEDURE NOT PER IFU. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. A DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED BREAK, MATERIAL DEFORMATION AND MATERIAL SEPARATION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. 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 USING THE CROSSER CATHETER. DURING THE PROCEDURE, AFTER PASSING THROUGH THE WIRE VASSALLO SUPPORT IN A RIGHT CFA CALCIFIED LESION VIA A LEFT CONTRALATERAL APPROACH, THE PATIENT ATTEMPTED TO INSERT THE WIRE INTO THE CROSSER IQ, BUT THE GUIDEWIRE WAS RELUCTANT TO GO IN AT ALL, AND THERE WAS NO WAY TO GET THE WIRE CAUGHT IN THE GUIDEWIRE PORT AND NO WAY TO GET THE WIRE OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.