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 FOR EVALUATION. UPON VISUAL INSPECTION, THE DEVICE WAS RETURNED WITH A GW LOADED WITHIN THE DEVICE. THE GW WAS PROTRUDING FROM BOTH THE GW EXIT PORT AND THE DISTAL TIP. NO ANOMALIES NOTED TO THE HANDLE. BEFORE FUNCTIONAL TESTING, THE DISTAL TIP WAS EXAMINED UNDER THE MICROSCOPE. PEELING OF THE SHEATH WAS NOTED OVER THE MARKER BAND. THE DISTAL END OF THE OUTER CATHETER WAS NOTED TO BE SWOLLEN AT THE MARKER BAND. THE GW LUMEN AND CORE WIRE WERE NOTED TO BE CROSSING OVER EACH OTHER. NO DAMAGE WAS NOTED TOO EITHER. THE RETURNED GW WAS PULLED PROXIMALLY FROM THE GW PORT WITHOUT RESISTANCE. IT WAS NOTED THE DISTAL TIP OF THE GW WAS THE SOFT TIP WHEN REMOVED AND ANGLED. THE GW LUMEN WAS FLUSHED WITH A SYRINGE VIA THE GW PORT, AND NO RESISTANCE WAS NOTED AS THE WATER EXITED FROM THE DISTAL TIP. THE RETURNED GW WAS INSERTED THROUGH THE DISTAL TIP; NO RESISTANCE WAS FELT DURING ADVANCEMENT. THE GW WAS ABLE TO ADVANCE AND EXIT OUT OF THE GW EXIT PORT. THE GW WAS RETRACTED WITHOUT ISSUE. NO FURTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING AND MATERIAL DEFORMATION AS THE PEELING OF THE SHEATH WAS NOTED OVER THE MARKER BAND AND ALSO THE DISTAL END OF THE OUTER CATHETER WAS NOTED TO BE SWOLLEN AT THE MARKER BAND. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AS THE GW WAS ABLE TO ADVANCE AND EXIT OUT OF THE GW EXIT PORT. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AND IDENTIFIED PEELING, 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 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 THE CROSSER IQ CATHETER. DURING THE PROCEDURE, IT WAS NOTICED THAT STRONG RESISTANCE ENCOUNTERED DURING GW PLACEMENT INTO THE IQ CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.