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 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. INVESTIGATIONAL SUMMARY: RECEIVED ONE 14S CROSSER CTO RECANALIZATION CATHETER FOR EVALUATION. NO ANOMALIES WERE NOTED WITH THE TRANSDUCER HANDLE OR SALINE HUB. A COMPLETE CIRCUMFERENTIAL FRACTURE WAS IDENTIFIED BETWEEN THE PROXIMAL PORTION OF THE CATHETER SHAFT AND THE STRAIN RELIEF. THE INNER GUIDEWIRE LUMEN WAS VISIBLE AT THE FRACTURE SITE AND REMAINED CONNECTED. THE MARKER BAND WAS PRESENT AND UNDAMAGED. A STYLET WAS OBSERVED LOADED WITHIN THE DISTAL TIP OF THE CATHETER; NO ADDITIONAL ANOMALIES WERE NOTED. PRIOR TO FUNCTIONAL TESTING, THE STYLET WAS SUCCESSFULLY REMOVED. DURING FUNCTIONAL TESTING, THE DEVICE WAS CONNECTED TO THE CROSSER GENERATOR AND FLOW MATE INJECTOR WITHOUT ISSUE AND ACTIVATED SUCCESSFULLY. UPON FLUSHING, LEAKAGE WAS OBSERVED AT THE STRAIN RELIEF, AND NO FLUID WAS OBSERVED EXITING THE DISTAL TIP. THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED CONNECTION PROBLEM, AS THE DEVICE WAS SUCCESSFULLY CONNECTED TO THE CROSSER GENERATOR AND ACTIVATED WITHOUT ISSUE DURING FUNCTIONAL TESTING. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK BETWEEN THE PROXIMAL CATHETER SHAFT AND THE STRAIN RELIEF. THE INVESTIGATION ALSO CONFIRMED FOR THE IDENTIFIED LEAK AT THE STRAIN RELIEF. THE IDENTIFIED BREAK IS CONSIDERED THE MOST LIKELY CAUSE OF THE OBSERVED LEAKAGE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CONNECTION PROBLEM, IDENTIFIED BREAK, IDENTIFIED LEAK 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.

Description of Event or Problem

A PATIENT WAS PREPPED FOR A RECANALIZATION PROCEDURE USING THE CROSSER CATHETER. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE CROSSER DEVICE HAD A CONNECTION PROBLEM. THERE WAS NO PATIENT CONTACT.