CROSSER IQ ULTRASONIC

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN ANTERIOR TIBIAL ARTERY VIA IPSILATERAL FEMORAL APPROACH USING THE CROSSER IQ ULTRASONIC CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY GOT STUCK AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE LUMEN WAS NOT ABLE TO BE FLUSHED. 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 FOR EVALUATION. UPON MICROSCOPIC OBSERVATION, THE MATERIAL SEPARATION WAS NOTED BETWEEN THE TITANIUM TIP AND OUTER SHEATH. DURING FUNCTIONAL TESTING, GW LUMEN WAS FLUSHED, IT WAS NOTED BLOODY WATER ALONG WITH BLOOD FILAMENTS WERE EXPELLED FROM THE DISTAL TIP AND THE FLUSHING TEST WAS PERFORMED WITHOUT ANY ISSUES. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DIFFICULT TO REMOVE AS INSERTING GW WAS NOT POSSIBLE DUE MATERIAL SEPARATION. THE INVESTIGATION IS UNCONFIRMED THE REPORTED FLUSHING PROBLEM AS THE GW LUMEN WAS FLUSHED WITHOUT ANY ISSUE AND THE INVESTIGATION IS CONFIRMED THE IDENTIFIED MATERIAL SEPARATION AS THE MATERIAL SEPARATION WAS NOTED BETWEEN THE TITANIUM TIP AND OUTER SHEATH. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DIFFICULT TO REMOVE, FLUSHING PROBLEM AND IDENTIFIED MATERIAL SEPARATION 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) #), E1, 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 IN ANTERIOR TIBIAL ARTERY VIA IPSILATERAL FEMORAL APPROACH USING THE CROSSER IQ ULTRASONIC CATHETER. DURING THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY GOT STUCK AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE LUMEN WAS NOT ABLE TO BE FLUSHED. THERE WAS NO REPORTED PATIENT INJURY.

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 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.