CROSSER IQ ULTRASONIC

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 VIA IPSILATERAL ANTEGRADE APPROACH USING A CROSSER IQ ULTRASONIC CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER TIP ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.

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, A TEAR AND MATERIAL DEFORMATION WAS NOTED TO THE STRAIN RELIEF. MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND OUTER CATHETER. THE OUTER CATHETER AND END OF THE GW LUMEN APPEARED TO BE JAGGED. IN ADDITION, PEELING OF THE SHEATH WAS NOTED OVER THE MARKER BAND. NO ANOMALIES NOTED TO THE HANDLE. NO FUNCTIONAL TESTING PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE.THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING OF THE SHEATH WAS NOTED OVER THE MARKER BAND. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED TEAR AND MATERIAL DEFORMATION WAS NOTED TO THE STRAIN RELIEF AND ALSO INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION WAS NOTED BETWEEN THE DISTAL TIP AND OUTER CATHETER. HOWEVER, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED DETACHMENT AS NO DETACHMENT WAS NOTED ON THE DEVICE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DETACHMENT AND IDENTIFIED MATERIAL SEPARATION, MATERIAL DEFORMATION, PEELING, TEAR 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. 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.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH USING A CROSSER IQ ULTRASONIC CATHETER. IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER TIP ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.