CROSSER IQ ULTRASONIC

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER IQ CATHETER. DURING THE PROCEDURE, WHEN INSERTED THE WIRE THROUGH THE ORANGE GUIDEWIRE LUMEN PORT, IT GOT STUCK AT THE TIP AND THE WIRE WOULD NOT COME OUT. IT WAS FURTHER REPORTED THAT THE END OF THE WIRE WAS INSERTED THROUGH THE TIP OF THE CATHETER AND THE GUIDEWIRE WAS INSERTED IN THE OPPOSITE DIRECTION; HOWEVER, THE GUIDEWIRE DID NOT COME OUT OF THE ORANGE PORT. THERE WAS NO REPORTED PATIENT INJURY.

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 AND AN UNKNOWN BRAND GUIDEWIRE LOADED INTO A GUIDEWIRE HOOP. A BEND WAS OBSERVED TO THE DISTAL END OF THE UNKNOWN BRAND GUIDEWIRE. A KINK WAS OBSERVED TO THE DISTAL END OF THE CATHETER. NO OTHER ANOMALIES WERE OBSERVED TO THE COMPLAINT SAMPLE. UPON VISUAL INSPECTION, IT WAS NOTED THE DISTAL END OF THE CATHETER WAS SLIGHTLY BENT. DURING FUNCTIONAL TESTING, THE GW LUMEN WAS FLUSHED WITH A SYRINGE VIA THE GW PORT AND BLOODY WATER EXITED FROM THE DISTAL TIP. AN ATTEMPT WAS MADE TO INSERT THE RETURNED .014 GUIDEWIRE THROUGH DISTAL TIP AND UPON REACHING THE GW PORT IT WOULD NOT EXIT. IT WAS NOTED THAT THE GW INSERTION THROUGH THE DISTAL TIP DID NOT INSERT IT INTO THE GW LUMEN OF THE DEVICE BUT RATHER STAYED IN THE WITHIN THE OUTER CATHETER DURING INSERTION. AN ATTEMPT WAS MADE VIA THE OTHER END OF THE OUTER CATHETER THROUGH THE GW PORT, BUT THE WIRE WAS MET WITH HIGH RESISTANCE AT THE DISTAL TIP WHEN ATTEMPTING TO EXIT. UNDER MICROSCOPE EXAMINATION, THE GW RESISTANCE AS FELT AT THE TITANIUM TIP WHICH DID NOT ALLOW THE GW FROM COMING THROUGH. THE GW WAS RETRACTED AND NO OTHER FUNCTIONAL TESTING WAS PERFORMED. UPON MICROSCOPIC OBSERVATION, IT WAS NOTED SALINE WAS PRESENT ON THE DISTAL TIP MICROSCOPIC ANALYSIS OF THE DISTAL TIP WAS CONDUCTED AND IT WAS NOTED THERE WAS A BREAK IN THE GW LUMEN. THE RETURNED GW WAS INSERTED VIA THE DISTAL TIP AND IT WAS EVIDENT THE GW WOULD NOT INSERT IN THE GW LUMEN OF THE CROSSER DUE TO THE BREAK. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE WIRE WAS MET WITH HIGH RESISTANCE AT THE DISTAL TIP WHEN ATTEMPTING TO EXIT. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED BREAK AND MATERIAL TWISTED AND/BENT AS THE GW LUMEN WAS NOTED TO BE BROKEN AS THE EVIDENCE PROVIDED UNDER MICROSCOPIC OBSERVATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY DUE TO THE BREAK AND MATERIAL TWISTED/BENT OF THE GW LUMEN. A DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED BREAK AND MATERIAL TWISTED/BENT 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 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.