LIMFLOW V-CEIVER

Description of Event or Problem

A PATIENT WITH CLTI (CHRONIC LIMB-THREATENING ISCHEMIA), CLASSIFIED AS RUTHERFORD CATEGORY 6, UNDERWENT A TADV PROCEDURE (TRANSCATHETER ARTERIALIZATION OF DEEP VEINS) USING THE LIMFLOW DEVICES ON (B)(6) 2024. DURING THE PROCEDURE, THE V-CEIVER WAS INSERTED INTO THE PATIENT'S LATERAL PLANTAR VEIN (LPV) OVER A COMMAND 0.014" GUIDEWIRE. THE GUIDEWIRE HAD TRAVERSED FROM THE POSTERIOR TIBIAL VEIN THROUGH A PERFORATOR AND TO THE PERONEAL VEIN. DUE TO THE TORTUOSITY OF THIS PATIENT'S VENOUS ANATOMY, THE V-CEIVER COULD NOT TRAVERSE THROUGH THE PERONEAL VEIN; THE PHYSICIAN ATTEMPTED TO DELIVER THE V-CEIVER BUT WAS UNSUCCESSFUL. THEY DECIDED TO RETRACT THE V-CEIVER AND SWITCH OUT THE WIRE FOR A STIFFER (V14) GUIDEWIRE HOWEVER THEY WERE STILL NOT ABLE TO DELIVER THE V-CEIVER IN THE PERONEAL VEIN. THE PHYSICIAN STARTED TO RETRACT THE DEVICE WHEN THE TIP BECAME STUCK AND DISCONNECTED FROM THE CATHETER. THE PHYSICIAN MADE AN EFFORT TO RETRIEVE THE DETACHED TIP BY BALLOONING PROXIMAL TO THE TOP IN ATTEMPT TO DRAG THE TIP DOWN INTO THE PEDAL SHEATH WITH NO SUCCESS. GIVEN THE INABILITY TO RETRIEVE THE TIP, THE DECISION WAS MADE TO LEAVE IT IN PLACE. TO PREVENT MIGRATION, A STENT WAS DEPLOYED OVER THE TIP.

Additional Manufacturer Narrative

THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNSUAL FINDINGS. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THERE HAVE BEEN NO SIMILAR COMPLAINT EVENTS FOR THIS LOT NUMBER. MANUFACTURER REFERENCE: (B)(4).