CROSSER IQ

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 DEVICE FOR EVALUATION. UPON MICROSCOPIC VISUAL OBSERVATION, MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND CATHETER SHEATH. DAMAGE WAS NOTED ON THE DISTAL END OF THE CATHETER SHEATH AS IT APPEARED TO BE JAGGED. PEELING WAS NOTED OVER THE MARKER BAND. DUE TO MATERIAL SEPARATION, NO FURTHER FUNCTIONAL TESTING WAS REQUIRED. THE INVESTIGATION IS CONFIRMED FOR THE MATERIAL SEPARATION AS THE MATERIAL SEPARATION WAS NOTED THE DISTAL TIP AND CATHETER SHEATH. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AS THE DISTAL END OF THE CATHETER WAS NOTED TO BE DAMAGED AND THE INVESTIGATION IS ALSO CONFIRMED FOR IDENTIFIED THE PEELING WAS NOTED OVER THE MARKER BAND. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION, IDENTIFIED MATERIAL DEFORMATION 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. B5, D4 (UNIQUE IDENTIFIER (UDI) #), G3, H6 (DEVICE, 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 IN THE SUPERFICIAL FEMORAL ARTERY USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE TIP ALLEGEDLY DETACHED BUT WAS STILL ATTACHED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN SUPERFICIAL FEMORAL ARTERY USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE TIP ALLEGEDLY DETACHED. 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 IS CURRENTLY BEING 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.