CROSSER

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS 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 (INSTRUCTION FOR USE) ARE 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 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 RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER ALLEGEDLY GOT STUCK IN THE ATA. FURTHER IT WAS REPORTED THAT PROXIMAL END OF THE CROSSER CATHETER WAS CUT AND THE CATHETER WAS DEFORMED. THE PATIENT EXPERIENCED VASCULAR DAMAGE AND BLEEDING. THE CURRENT STATUS OF PATIENT WAS UNKNOWN.

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER 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. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED MATERIAL DEFORMATION AND RETRACTION PROBLEM 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. B5, G3, H4. 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

A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING A CROSSER CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER ALLEGEDLY BECAME STUCK IN THE ANTERIOR TIBIAL ARTERY (ATA) AND COULD NOT BE REMOVED. IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE CROSSER CATHETER WAS CUT, AND A GUIDING CATHETER WAS ADVANCED OVER IT IN AN ATTEMPT TO RESOLVE THE BLOCKAGE. REPORTEDLY, THE CATHETER BECAME DEFORMED, PREVENTING IT FROM BEING FULLY RETRACTED INTO THE SHEATH. FURTHERMORE, DURING SHEATH REMOVAL, THE EXPOSED DISTAL END OF THE CATHETER WAS PULLED OUT, RESULTING IN VASCULAR DAMAGE AND BLEEDING. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.