POWERWIRE RADIOFREQUENCY GUIDEWIRE

Additional Manufacturer Narrative

BASED ON THE LIMITED INFORMATION AVAILABLE, IT IS UNKNOWN IF HEMOTHORAX OCCURRED IN THE PATIENT TREATED WITH POWERWIRE. HOWEVER, AS A BAYLIS MEDICAL TECHNOLOGIES DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL TECHNOLOGIES HAS DECIDED TO SUBMIT THIS REPORT.

Description of Event or Problem

IN A PRE-PRINT RETROSPECTIVE REVIEW OF CASES FROM 2015-2025, IT WAS IDENTIFIED THAT POWERWIRE WAS USED AMONG OTHER SHARP RECANILIZATION TECHNIQUES. WITHIN THIS COHORT, ONE PATIENT UNDERWENT RADIOFREQUENCY WIRE RECANALIZATION USING THE POWERWIRE. THE STUDY REPORTED THAT THREE PATIENTS IN THE SHARP RECANALIZATION GROUP DEVELOPED SMALL HEMOTHORACES. THE AVAILABLE INFORMATION DOES NOT IDENTIFY WHICH PATIENT(S) EXPERIENCED THE HEMOTHORACES; THEREFORE, IT CANNOT BE CONFIRMED WHETHER A HEMOTHORAX OCCURRED IN THE PATIENT TREATED WITH POWERWIRE. BASED ON THE LIMITED INFORMATION AVAILABLE, IT ALSO CANNOT BE CONFIRMED THAT POWERWIRE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED HEMOTHORAX. FROM ARTICLE: "A TOTAL OF 13 PATIENTS UNDERWENT SHARP RECANALIZATION. OF THESE PATIENTS, 1 PATIENT UNDERWENT RADIOFREQUENCY WIRE RECANALIZATION WITH A RFA -WIRE (POWERWIRE, BAYLIS MEDICAL TECH FORTH WORTH, TX) WHICH WAS UNSUCCESSFUL. ELEVEN PATIENTS UNDERWENT RECANALIZATION WITH A CHIBA NEEDLE AND 1 WITH COLAPINTO NEEDLE, OF WHICH 10 PATIENTS WERE SUCCESSFULLY RECANALIZED (77% SUCCESS). CENTRAL VENOGRAM SHOWED ABRUPT MORPHOLOGY OCCLUSION IN 10 CASES AND TAPERED MORPHOLOGY OCCLUSION IN 3 CASES. RECANALIZATION WAS SUCCESSFUL IN 7/10 CASES WITH ABRUPT MORPHOLOGY AND 3/3 CASES WITH TAPERED MORPHOLOGY (70% VS 100%). (P=.24). 12/13 PATIENTS WHO UNDERWENT SUCCESSFUL RECANALIZATION WITH A CHIBA NEEDLE HAD SUBSEQUENT STENT PLACEMENT." "THERE WERE THREE PATIENTS WHO HAD SMALL HEMOTHORACES AFTER SHARP RECANALIZATION CASES THAT DID NOT REQUIRE ADDITIONAL INTERVENTIONS THERE WERE NO DEATHS OR CASES OF HEMOPERICARDIUM." SIDDIQUI ET AL., 2026 HTTPS://DOI.ORG/10.21203/RS.3.RS-9503335/V1.