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. UPON VISUAL INSPECTION, IT WAS NOTED THE DISTAL TIP WAS NOT ATTACHED TO THE OUTER CATHETER RATHER WAS RECEIVED IN A SPECIMEN CUP. MARKER BAND WAS NOT RETURNED OR ON THE OUTER CATHETER. THE DISTAL TIP WAS RECEIVED DETACHED WITH PARTIAL CORE WIRE STILL ATTACHED AND SEPARATED MULTIPLE PIECES OF CORE WIRE. THE DISTAL END OF THE CATHETER WAS NOTED HAVE JAGGED END AND TO HAVE MULTIPLE TEARS AND HOLES. UNDER LIGHT, THE REMAINING CORE WIRE COULD BE SEEN WITHIN THE CATHETER. FURTHER, MICROSCOPIC VISUAL OBSERVATION WAS PERFORMED FOR THE ANOMALIES NOTED NEAR THE DISTAL TIP. IN ADDITION, THE RETURNED CORE WIRE OD PIECES WERE MEASURED, HOWEVER THERE WERE 4 PIECES ORIGINALLY AND ONE OF THE CORE WIRES BROKE INTO A SMALLER SEGMENT. NO OTHER FUNCTIONAL TESTING PERFORMED DUE TO THE DETACHED CORE WIRE. FOUR ELECTRONIC PHOTOS WERE RECEIVED AND REVIEWED. THE FIRST PHOTO SHOWS THE CATHETER SHEATH AND BROKEN CORE WIRE FRAGMENTS. THE SECOND PHOTO SHOWS THE PERSON HOLDING THE GW LUMEN. THE THIRD AND FOURTH PHOTO SHOWS THE CATHETER SHEATH, CATHETER GW LUMEN WITH MARKER BAND AND BROKEN CORE WIRE FRAGMENTS. ONE ELECTRONIC VIDEO WAS RECEIVED AND REVIEWED. THE VIDEO REVIEW SHOWS THE PERSON HOLDING THE CATHETER AND WATER WAS LEAKING FROM THE DISTAL END OF THE CATHETER. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DETACHMENT AS THE DISTAL TIP AND MARKER BAND WAS NOTED TO BE DETACHED FROM THE CATHETER AND THE CORE WIRE WAS BROKEN INTO SMALLER SEGMENTS. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED MATERIAL TEAR AS IT WAS NOTED ON THE DISTAL END OF THE CATHETER. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED HOLE AS THE MULTIPLE HOLES WAS NOTED ON THE CATHETER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT, IDENTIFIED TEAR AND HOLE 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. 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 CROSSER IQ CATHETER. PRIOR TO THE PROCEDURE, THE CATHETER WAS FLUSHED, WHILE FEEDING THE WIRE ONTO THE CATHETER, IT WAS FOUND THAT THE CATHETER WAS ALLEGEDLY FRACTURED COMPLETELY AND SNAPPED INTO MULTIPLE PIECES.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER IQ CATHETER. PRIOR TO THE PROCEDURE, THE CATHETER WAS FLUSHED, WHILE FEEDING THE WIRE ONTO THE CATHETER, IT WAS FOUND THAT THE CATHETER WAS ALLEGEDLY FRACTURED COMPLETELY AND SNAPPED INTO MULTIPLE PIECES.

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. HOWEVER, PHOTOS AND VIDEOS WERE PROVIDED FOR REVIEW. 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.