CROSSER IQ

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: RECEIVED ONE CROSSER IQ ULTRASONIC CTO DEVICE FOR EVALUATION. UPON VISUAL INSPECTION, NO ANOMALIES WERE NOTED TO THE TRANSDUCER HANDLE OR SALINE PORT. THE MARKER BAND WAS PRESENT WITH NO ANOMALIES. UPON MICROSCOPIC OBSERVATION, THERE IS A TEAR IN THE INNER GW LUMEN THAT ALLOWS THE IN-HOUSE GW TO GO THRU AND THUS OUTSIDE THE GW LUMEN OVERALL. DURING FUNCTIONAL TESTING, AFTER MULTIPLE ATTEMPTS WERE MADE TO INSERT THE GW IN THE LUMEN, IT WAS ABLE TO ENTER THE LUMEN TO EXIT OUT OF THE GW PORT. HOWEVER, THIS WAS SUCCESSFUL ONLY AFTER MANIPULATING THE GW AND CHANGING THE ANGLE TO BE ABLE TO INSERT IN THE GW LUMEN. THE INVESTIGATION IS UNCONFIRMED THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE GW WAS ABLE TO ENTER THE LUMEN AND EXIT OUT OF THE GW PORT. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED TEAR IN THE GW LUMEN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY MAY BE DUE TO THE TEAR OF GW LUMEN AND ROOT CAUSE FOR THE IDENTIFIED TEAR COULD NOT BE DETERMINED BASED ON 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 BARD 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 IQ CATHETER. PRIOR TO THE PROCEDURE, THE GUIDEWIRE ALLEGEDLY DID NOT PASS THROUGH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.