CROSSER IQ ULTRASONIC

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: RECEIVED ONE CROSSER IQ ULTRASONIC CTO DEVICE LOADED ONTO A PACKAGING HOOP. THE COMPLAINT SAMPLE APPEARED TO HAVE RESIDUE THROUGHOUT. NO ANOMALIES WERE OBSERVED TO THE COMPLAINT SAMPLE UPON, VISUAL EVALUATION: MARKER BAND IS PRESENT AND UNDAMAGED. THE TITANIUM TIP APPEARED TO BE SLIGHTLY CROOKED ON THE CATHETER (REFERENCE MICROSCOPIC IMAGE). DURING FUNCTIONAL TESTING, THE GW LUMEN WAS FLUSHED WITH A SYRINGE VIA THE GW PORT AND WATER EXITED FROM THE DISTAL TIP. AN ATTEMPT WAS MADE TO INSERT THE IN-HOUSE .014 GUIDEWIRE THROUGH DISTAL TIP AND UPON REACHING THE GW PORT IT WOULD NOT EXIT. IT WAS NOTED THAT THE GW INSERTION THROUGH THE DISTAL TIP DID NOT INSERT IT INTO THE GW LUMEN OF THE DEVICE BUT RATHER STAYED WITHIN THE OUTER CATHETER DURING INSERTION. AN ATTEMPT WAS MADE VIA THE OTHER END OF THE OUTER CATHETER THROUGH THE GW PORT, BUT THE WIRE WAS MET WITH HIGH RESISTANCE AT THE DISTAL TIP WHEN ATTEMPTING TO EXIT. UNDER MICROSCOPE EXAMINATION, IT WAS NOTED THE RESISTANCE STARTED ONCE THE GW REACHED THE MARKER BAND. IT APPEARED THE COREWIRE OF THE TITANIUM TIP DID NOT ALLOW THE GW TO PASS THROUGH TO EXIT OUT OF THE DISTAL TIP. THE GW WAS RETRACTED, AND NO OTHER FUNCTIONAL TESTING WAS PERFORMED. UPON MICROSCOPIC VISUAL OBSERVATION. THE GW LUMEN WAS FLUSHED WITH A SYRINGE VIA THE GW PORT AND WATER EXITED FROM THE DISTAL TIP. AN ATTEMPT WAS MADE TO INSERT THE IN-HOUSE .014 GUIDEWIRE THROUGH DISTAL TIP; HOWEVER, IT DID NOT ENTER THE GW LUMEN AS THERE WAS A TEAR AND TWISTING OF THE GW LUMEN. MICROSCOPIC IMAGES WERE TAKEN OF THE DAMAGE SEEN PROXIMAL TO THE MARKER BAND. THE TEAR DID NOT ALLOW THE GW TO ENTER THE LUMEN BUT RATHER REDIRECT TO THE OUTER CATHETER SHEATH. NO FURTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY AS THE WIRE WAS MET WITH HIGH RESISTANCE AT THE DISTAL TIP WHEN ATTEMPTING TO EXIT. THE INVESTIGATION IS ALSO CONFIRMED FOR THE IDENTIFIED TEAR AND TWIST OF THE GW LUMEN AS THE EVIDENCE PROVIDED UNDER MICROSCOPIC OBSERVATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED DEVICE-DEVICE INCOMPATIBILITY DUE TO THE TEAR AND TWIST OF GW LUMEN. A DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED TEAR AND TWIST 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 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 CROSSER IQ ULTRASONIC. PRIOR TO THE PROCEDURE THE WIRE WAS ALLEGEDLY FAILED TO INSERT INTO THE CROSSER IQ CATHETER FROM THE TIP. NO PATIENT INJURY.