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, IT WAS NOTED THERE WAS MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND THE SHEATH. UNDER LIGHT MICROSCOPE, THE SHEATH WAS JAGGED WHERE THE MATERIAL SEPARATION WAS PRESENT. NO ANOMALIES WERE NOTED TO THE TRANSDUCER HANDLE AND MARKER BAND WAS PRESENT. NO FUNCTIONAL TESTING COULD BE PERFORMED SUCH AS FLUSHING AND INSERTING AN IN-HOUSE GW COULD NOT BE PERFORMED ON DEVICE DUE TO THE CONDITION OF MATERIAL SEPARATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AND FLUSHING PROBLEM AS THE FUNCTIONAL TEST IS NOT PERFORMED DUE TO THE CONDITION OF MATERIAL SEPARATION. ALTHOUGH, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION AS THE MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND THE SHEATH. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY, FLUSHING PROBLEM AND IDENTIFIED MATERIAL SEPARATION 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. 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 ANTERIOR TIBIAL ARTERY USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY COULD NOT BE INSERTED INTO THE ORANGE HUB. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.