CROSSER IQ ULTRASONIC

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE CATHETER TIP WAS ALLEGEDLY SEPARATED. IT WAS FURTHER REPORTED THAT IT WAS STILL ATTACHED TO THE CORE WIRE AND MARKERS APPEARED TOO FAR APART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE 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 DEVICE FOR EVALUATION. UPON VISUAL INSPECTION, MATERIAL SEPARATION WAS NOTED BETWEEN THE CATHETER AND THE TITANIUM DISTAL TIP. THE GW LUMEN WAS EXTENDING OUT FROM THE AREA OF THE MATERIAL SEPARATION. MARKER BAND WAS PRESENT AND UNDAMAGED. NO ANOMALIES TO THE HANDLE. THE SALINE SPIKE AND DRIPPER WERE NOT RETURNED. DUE TO RETURNED CONDITION OF THE DEVICE, FUNCTIONAL TESTING WAS NOT PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL SEPARATION BETWEEN THE CATHETER AND THE TITANIUM DISTAL TIP, AND THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED DEVICE DISLODGED OR DISLOCATED AS THE MARKER BAND WAS PRESENT AND UNDAMAGED. PER THE EVENT REPORTED DETAILS THE MARKER BANDS LIKELY APPEARED FAR APART DUE TO THE MATERIAL SEPARATION. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL SEPARATION AND DEVICE DISLODGED OR DISLOCATED 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. D4 (UNIQUE IDENTIFIER (UDI) #), 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.

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING 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 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 THE CROSSER CATHETER. DURING THE PROCEDURE, THE CATHETER TIP WAS ALLEGEDLY SEPARATED. IT WAS FURTHER REPORTED THAT IT WAS STILL ATTACHED TO THE CORE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.