JETSTREAM Atherectomy Catheter

Description of Event or Problem

IT WAS REPORTED PER LITERATURE THAT DISTAL EMBOLIZATION OCCURRED DURING USE OF THE DEVICE. IN A REVIEW OF PREVIOUS STUDIES OF ATHERECTOMY PROCEDURES AND THEIR ASSOCIATION WITH DISTAL EMBOLIZATION, IN VITRO TESTING WAS PERFORMED TO EVALUATE THE CAUSES OF DISTAL EMBOLIZATION DESPITE THE USE OF EMBOLIC PROTECTION DEVICES (EPDS) DURING ATHERECTOMY PROCEDURES. DURING A JETSTREM PROCEDURE, DISTAL EMBOLIZATION MAY HAVE BEEN ASSOCIATED WITH INADEQUATE FILTER FIXATION, WHICH MAY HAVE ALLOWED FILTER MIGRATION DURING DEVICE DELIVERY AND RETRIEVAL ENABLING DEBRIS TO ESCAPE. ADDITIONAL IN VITRO TESTING UNDER FLOW-CONTROLLED ATHERECTOMY TREATMENT (FCAT) SHOWED THAT DEBRIS BECAME DISLODGED DURING JETSTREAM ATHERECTOMY AND WAS THEN EXPELLED BY THE DEVICES SALINE FLUSH.

Additional Manufacturer Narrative

B3: DATE OF EVENT: ESTIMATED BASED ON ARTICLE PUBLICATION DETAILED PRODUCT AND PATIENT INFORMATION WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ARTICLE TITLE: ATHERECTOMY WITH MULTIMODAL EMBOLIC PROTECTION FOR SEVERELY CALCIFIED FEMOROPOPLITEAL LESIONS. ARTICLE CITATION: D. YOSHII, O. IIDA, T. TOYOSHIMA, AND Y. OKINA, 'ATHERECTOMY WITH MULTIMODAL EMBOLIC PROTECTION FOR SEVERELY CALCIFIED FEMOROPOPLITEAL LESIONS,' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS107 (2026): 1350-1354, HTTPS://DOI.ORG/10.1002/CCD.70479.