CROSSER IQ ULTRASONIC

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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 CHRONIC TOTAL OCCLUSION CROSSER IQ CATHETER TO TREAT THE ATA SEVERELY CALCIFIED LESION. DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE LESION IN THE DISTAL PART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ADVANCED ANOTHER 5 CM DISTALLY, BUT THE CATHETER WAS STUCK IN THE BLOOD VESSEL, THE CATHETER COULD NOT BE PULLED OUT AND IT WAS IN A STATE OF THERMAL RUPTURE AS IF IT HAD BEEN BURNT. REPORTEDLY, THE TIP HAD SHRUNK LIKE A BELLOWS AND WAS DROOPING FROM HEAT AND THE BLOOD VESSEL WAS RUPTURED WHEN THE SYSTEM WAS REMOVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE CROSSER IQ ULTRASONIC CTO DEVICE WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, IT WAS NOTED THE DISTAL END OF THE CATHETER WAS BUNCHED AND APPEARED TO BE BURNT. THE DISTAL TIP WAS NOTED TO BE SEPARATED FROM THE SHEATH BUT STILL ATTACHED TO THE CORE WIRE. THE MARKER BAND WAS PRESENT BUT WAS DAMAGED AS IT WAS BEND. THERE WAS ONE KINK DISTAL TO THE STRAIN RELIEF. UPON FUNCTIONAL AND MICROSCOPIC VISUAL EVALUATION, DUE TO THE CONDITION OF DEVICE SUCH AS BURNT AND BUNCHING, NO FUNCTIONAL TESTING CAN BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THEREFORE, THE INVESTIGATION REMAINS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE, ENTRAPMENT OF DEVICE AND OVERHEATING OF DEVICE AS THE CONDITION DOES NOT ALLOW FUNCTIONAL TESTING AND REPLICATION OF ENTRAPMENT OF DEVICE, OVERHEATING. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MELTING AS THE DISTAL END OF THE CATHETER WAS NOTED TO BE MELTED. AND THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION AND DEFORMATION AS THE SEPARATION AND DEFORMATION WERE NOTED TO THE DISTAL END OF THE CATHETER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE, ENTRAPMENT OF DEVICE, OVERHEATING OF DEVICE, MELTED AND IDENTIFIED SEPARATION, DEFORMATION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELLING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G2, G3, H6 (DEVICE, COMPONENT, METHOD, RESULT, CONCLUSION). 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 CTO CROSSER IQ CATHETER TO TREAT THE ATA SEVERELY CALCIFIED LESION. DURING THE PROCEDURE, THE CATHETER COULD NOT BE PASSED THROUGH THE LESION IN THE DISTAL PART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ADVANCED ANOTHER 5 CM DISTALLY, BUT THE CATHETER WAS STUCK IN THE BLOOD VESSEL, THE CATHETER COULD NOT BE PULLED OUT AND IT WAS IN A STATE OF THERMAL RUPTURE AS IF IT HAD BEEN BURNT. REPORTEDLY, THE TIP HAD SHRUNK INTO A BELLOW SHAPE AND WAS DROOPING FROM HEAT. THE BLOOD VESSEL WAS RUPTURED WHEN THE SYSTEM WAS REMOVED. FURTHER, COIL EMBOLIZATION WAS PERFORMED AND THE PROCEDURE WAS TERMINATED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.