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, MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND OUTER CATHETER. IN ADDITION, PEELING OF THE SHEATH WAS NOTED OVER THE MARKER BAND. NO ANOMALIES NOTED TO THE HANDLE. NO FUNCTIONAL TESTING PERFORMED DUE TO MATERIAL SEPARATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AS NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING OVER THE MARKER BAND, AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION BETWEEN THE DISTAL TIP AND OUTER CATHETER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AND IDENTIFIED PEELING, 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 USING A CROSSER CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE WAS REPORTEDLY UNABLE TO BE INSERTED INTO THE WIRE PORT. THERE WAS NO REPORTED PATIENT INJURY.