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 DEVICE WITH AN UNKNOWN BRAND GUIDEWIRE IN A GUIDEWIRE HOOP. UPON VISUAL INSPECTION, IT WAS NOTED THE DISTAL PORTION OF THE CATHETER WAS DAMAGED. UNDER MICROSCOPIC ANALYSIS, THERE WAS BUNCHING AND JAGGEDNESS TO THE OUTER SHEATH NEAR THE DISTAL END. BUNCHING WAS PRESENT OVER THE MARKER BAND. IN ADDITION, PARTIAL MATERIAL SEPARATION WAS NOTED AT THE DISTAL TIP. DUE TO MATERIAL SEPARATION AND MATERIAL DEFORMATION, FUNCTIONAL TESTING FOR GW INCOMPATIBILITY COULD NOT BE PERFORMED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE CONDITION OF USE CANNOT BE RECREATED. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION AS THE PARTIAL MATERIAL SEPARATION WAS NOTED ON THE DISTAL TIP, AND THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED MATERIAL DEFORMATION AS THE BUNCHING AND JAGGEDNESS TO THE OUTER SHEATH NEAR THE DISTAL END. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY, IDENTIFIED MATERIAL SEPARATION AND MATERIAL DEFORMATION 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. 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 USING CROSSER CATHETER. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED TO THE BK AND ACTIVATED, IT WAS STUCK WITH THE GUIDEWIRE, AND THE ENTIRE SYSTEM HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.