CROSSER

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. 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.

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, THE TIP ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. IT WAS REPORTED THAT THE EVENT OCCURRED UPON OFF LABEL AS THE TIP OF THE CROSSER WAS NOTED TO BE MISALIGNED UPON OPENING BUT USED ON PATIENT. BD CTO CROSSER RECANALIZATION SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, PRIOR TO USE, THE PACKAGING AND PRODUCT SHOULD BE INSPECTED FOR SIGNS OF DAMAGE. NEVER USE DAMAGED PRODUCT OR PRODUCT FROM A DAMAGED PACKAGE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED IMPROPER OR INCORRECT PROCEDURE AS THE DEVICE WAS USED OFF LABEL AND AGAINST THE IFU WHICH IS USER-RELATED ISSUE. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED MATERIAL SEPARATION ISSUE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. PER THE IFU, THE PACKAGING AND PRODUCT SHOULD BE INSPECTED FOR SIGNS OF DAMAGE. THIS DEVIATION FROM THE IFU COULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE REPORTED MATERIAL SEPARATION. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: PRIOR TO USE, THE PACKAGING AND PRODUCT SHOULD BE INSPECTED FOR SIGNS OF DAMAGE. NEVER USE DAMAGED PRODUCT OR PRODUCT FROM A DAMAGED PACKAGE. IT WAS REPORTED THAT THE EVENT OCCURRED UPON OFF LABEL AS THE TIP OF THE CROSSER WAS NOTED TO BE MISALIGNED UPON OPENING BUT USED ON PATIENT. THEREFORE, THE REPORTED INCORRECT PROCEDURE IS CONFIRMED AS THE DEVICE WAS USED OFF LABEL AND AGAINST THE INSTRUCTIONS FOR USE. B5, G3, H6 (DEVICE, 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 USING THE CROSSER CATHETER. DURING THE PROCEDURE, WHEN OPENED THE CROSSER CATHETER, THE TIP WAS SLIGHTLY MISALIGNED WITH THE HYPOTUBE, BUT CONTINUED TO USE AND THE TIP BROKE AFTER THE FIRST USE. REPORTEDLY, DAMAGED PRODUCT WAS USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.