CROSSER

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE CROSSER CTO RECANALIZATION CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE AND SALINE HUB. A COMPLETE CIRCUMFERENTIAL BREAK WAS NOTED ON THE CATHETER, PROXIMAL TO THE STRAIN RELIEF. MARKER BAND IS PRESENT AND UNDAMAGED. NO ANOMALIES WERE NOTED TO THE DISTAL PORTION OF THE CATHETER AND REST OF THE COMPLAINT SAMPLE. NO FUNCTIONAL EVALUATION WAS PERFORMED DUE TO THE COMPLETE CIRCUMFERENTIAL BREAK ON THE CATHETER. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LEAK AS THE CONDITION OF THE DEVICE IS NOT SUITABLE FOR THE EVALUATION. BUT THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK AS THE COMPLETE CIRCUMFERENTIAL BREAK WAS NOTED TO THE STRAIN RELIEF. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK AND BREAK COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. 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 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 CTO CROSSER CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT SALINE LEAKED FROM NEAR THE BASE OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.