CROSSER IQ ULTRASONIC

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER TO TREAT AN ATA WITH SEVERE CALCIFICATION. PRIOR TO THE PROCEDURE, THE SETUP WAS PROCEEDING ACCORDING TO THE MANUAL, BUT THE MONITOR DISPLAYED THE MESSAGE PLUG IN DEVICE CONNECTOR TO COMPLETE PRIME, THE PRIMING COMPLETION LAMP DID NOT LIGHT UP, AND THE CATHETER DID NOT FUNCTION. RESTARTING THE DEVICE AND OTHER ATTEMPTS DID NOT IMPROVE THE SITUATION, SO THE DEVICE WAS ABANDONED. THERE WAS NO PATIENT CONTACT.

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 CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. MARKER BAND IS PRESENT AND UNDAMAGED. MICROSCOPIC IMAGE WAS TAKEN OF THE CONNECTOR HUB AND NO ANOMALIES NOTED. UPON FUNCTIONAL EVALUATION, THE DEVICE WAS CONNECTED TO THE IN-HOUSE SALINE TUBING AND CONNECTED TO THE BD RECANALIZATION SYSTEM AND PRIMED WITHOUT ISSUE. THEN THE MESSAGE "PLUG THE DEVICE CONNECTOR TO COMPLETE PRIME" APPEARED. THE POWER CABLE FROM THE CROSSER IQ WAS THEN CONNECTED TO THE BD RECANALIZATION SYSTEM. FOLLOWING CONNECTION, THE BD RECANALIZATION SYSTEM STATED, "CONNECT DEVICE". AFTER DISCONNECTING AND RECONNECTING THE CROSSER IQ DEVICE, THE MESSAGE CONTINUED TO DISPLAY EVEN AFTER MULTIPLE ATTEMPTS. THE HANDLE WAS THEN CUT OPEN, AND ALL COMPONENTS WERE EXAMINED. NO LOOSE CABLES WERE NOTED OR LOOSE CONNECTIONS. THE RIBBON CABLE HAD A SCRATCH MARK IN THE MIDDLE AND WAS NOTED TO BE LIFTED FROM HANDLE. NO OTHER FUNCTIONAL TESTING PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED CONNECTION PROBLEM AS THE DEVICE CONNECTED PROPERLY IT DISPLAYED ¿PLUG THE DEVICE CONNECTOR TO COMPLETE PRIME¿. AFTER SEVERAL ATTEMPTS OF CONNECTION, IT SHOWED ¿CONNECT DEVICE¿. ALSO, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED MATERIAL SPLIT AS THE RIBBON CABLE WAS NOTED TO BE SCRATCHED. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED CONNECTION ISSUE AND MATERIAL SPLIT 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 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: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE CROSSER IQ CATHETER WAS RECEIVED FOR EVALUATION. NO VISUAL ANOMALIES WERE NOTED TO THE EXTERNAL OF THE DEVICE. THE DEVICE WAS PHYSICALLY CONNECTED TO THE IN-HOUSE SALINE TUBING AND TO THE BD RECANALIZATION SYSTEM WITHOUT ISSUE. THE POWER CABLE FROM THE CROSSER IQ WAS THEN CONNECTED TO THE BD RECANALIZATION SYSTEM. FOLLOWING CONNECTION, THE BD RECANALIZATION SYSTEM STATED, "CONNECT DEVICE". AFTER DISCONNECTING AND RECONNECTING THE CROSSER IQ DEVICE, THE MESSAGE CONTINUED TO DISPLAY EVEN AFTER MULTIPLE ATTEMPTS. THE HANDLE WAS THEN CUT OPEN, AND THE RIBBON CABLE WAS NOTED TO BE SCRATCHED INSIDE THE HANDLE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED CONNECTION PROBLEM AS THE DEVICE WAS UNABLE TO BE RECOGNIZED BY THE SYSTEM. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED MATERIAL SPLIT AS THE RIBBON CABLE WAS NOTED TO BE SCRATCHED INSIDE THE HANDLE. THE ROOT CAUSE OF THE CONNECTION PROBLEM WAS DETERMINED TO BE DUE TO THE DAMAGED INTERNAL RIBBON CABLE. AS THE RIBBON CABLE IS FULLY INTERNAL AND WAS FOUND TO BE SCRATCHED UPON OPENING THE HANDLE, THE FAILURE WAS DETERMINED TO BE LIKELY MANUFACTURING RELATED. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. G3, H6 (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 CATHETER TO TREAT AN ATA WITH SEVERE CALCIFICATION. PRIOR TO THE PROCEDURE, THE SETUP WAS PROCEEDING ACCORDING TO THE MANUAL, BUT THE MONITOR DISPLAYED THE MESSAGE PLUG IN DEVICE CONNECTOR TO COMPLETE PRIME, THE PRIMING COMPLETION LAMP DID NOT LIGHT UP, AND THE CATHETER DID NOT FUNCTION. RESTARTING THE DEVICE AND OTHER ATTEMPTS DID NOT IMPROVE THE SITUATION, SO THE DEVICE WAS ABANDONED. THERE WAS NO PATIENT CONTACT.