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: ONE CROSSER IQ ULTRASONIC CTO DEVICE LOADED ONTO A PACKAGING HOOP. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. SALINE RESIDUE WAS NOT NOTED TO THE DISTAL END OF THE CATHETER SHAFT. THE MARKER BAND IS PRESENT AND UNDAMAGED. THE CATHETER SHAFT WAS FLUSHED PRIOR TO FUNCTIONAL TESTING. NO RESISTANCE WAS FELT DURING ATTEMPT. DURING FUNCTIONAL TESTING, THE GUIDEWIRE WAS NOT ABLE ADVANCE COMPLETELY THROUGHOUT THE CATHETER THAT WAS SUPPOSED TO EXIT AT THE HUB. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE AS THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CATHETER SHAFT. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED ON THE DISTAL END OF THE CATHETER. THE IDENTIFIED MATERIAL SEPARATION LIKELY CONTRIBUTED TO THE REPORTED GUIDEWIRE ISSUES. HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AND IDENTIFIED MATERIAL SEPARATION 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. G3, H6 (RESULT). 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

A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER IQ CATHETER TO TREAT LESION IN THE ANTERIOR TIBIAL ARTERY VIA IPSILATERAL APPROACH. DURING THE PROCEDURE, THE GUIDEWIRE GOT MIGRATED TO A DIFFERENT ROUTE IN THE PRODUCT. IT WAS FURTHER REPORTED THAT THE WIRE WAS INSERTED FROM THE TIP INTO THE WIRE PORT TO USE AGAIN, BUT THE WIRE DID NOT COME OUT OF THE WIRE PORT. REPORTEDLY, THE PRESENCE OF THE WIRE WAS CONFIRMED IN THE BLUE LUMEN AT THE BASE OF THE WIRE PORT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Description of Event or Problem

A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER IQ CATHETER TO TREAT LESION IN THE ANTERIOR TIBIAL ARTERY VIA IPSILATERAL APPROACH. DURING THE PROCEDURE, THE GUIDEWIRE GOT MIGRATED TO A DIFFERENT ROUTE IN THE PRODUCT. IT WAS FURTHER REPORTED THAT THE WIRE WAS INSERTED FROM THE TIP INTO THE WIRE PORT TO USE AGAIN, BUT THE WIRE DID NOT COME OUT OF THE WIRE PORT. REPORTEDLY, THE PRESENCE OF THE WIRE WAS CONFIRMED IN THE BLUE LUMEN AT THE BASE OF THE WIRE PORT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. 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 LOADED ONTO A PACKAGING HOOP. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. SALINE RESIDUE WAS NOT NOTED TO THE DISTAL END OF THE CATHETER SHAFT. THE MARKER BAND IS PRESENT AND UNDAMAGED. DURING FUNCTIONAL TESTING, THE CATHETER SHAFT WAS FLUSHED PRIOR TO FUNCTIONAL TESTING. NO RESISTANCE WAS FELT DURING ATTEMPT. AN IN-HOUSE 0.014" GUIDEWIRE WAS USED FOR TESTING AND AN ATTEMPT TO LOAD THE IN-HOUSE GUIDEWIRE THROUGH THE GUIDEWIRE PORT (ORANGE PORT) WAS PERFORMED. SLIGHT RESISTANCE WAS FELT AS THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CATHETER SHAFT SUCCESSFULLY, BUT THE GUIDEWIRE WAS NOT EXPOSED AT THE DISTAL TIP OF THE CATHETER SHAFT AS IT DID NOT ADVANCE ANYMORE. THE GUIDEWIRE WAS RETRACTED WITH SLIGHT RESISTANCE. THE MATERIAL SEPARATION ON THE DISTAL END OF THE CATHETER WAS NOTED, AFTER REMOVING THE IN-HOUSE GUIDEWIRE. RESISTANCE WAS FELT WHEN ADVANCING THE GUIDEWIRE DUE TO THE INCIDENTAL FINDING DURING VISUAL EXAMINATION. THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE AS THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CATHETER SHAFT SUCCESSFULLY AND RETRACTED WITH SLIGHT RESISTANCE. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SEPARATION AS THE SEPARATION WAS NOTED ON THE DISTAL END OF THE CATHETER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED GUIDEWIRE INCOMPATIBILITY AND IDENTIFIED MATERIAL SEPARATION 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. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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.