A philips representative became aware on 14 june 2021 of a peripheral atherectomy procedure, performed (b)(6) 2021 in which the physician used a spectranetics 2.3 turbo elite laser atherectomy catheter.Although the representative was not at the procedure, it was reported that treatment of a stenosis or lesion was being performed in a moderately fibrous area in the popliteal artery.At the time of the (b)(6) procedure, there were no reported issues and the procedure was completed.However, after the procedure, it was reported that the patient''s symptoms did not resolve and so a duplex scan was performed.The scan showed "something had shut down", but they were not sure what, so a subsequent procedure was performed on (b)(6) 2021.In this procedure on (b)(6), the philips representative was present at the procedure.It as identified that the turbo elite 2.3 device''s distal marker band had reportedly detached during the procedure on (b)(6), not discovered at that time, and during the first fluoroscopic images taken during the (b)(6) procedure, the marker band was confirmed to be present in the patient''s popliteal artery.The physician utilized a spectranetics quick-cross support catheter to begin to treat the patient.Once the quick-cross catheter reached the popliteal artery, it was reported that the quick-cross''s fluoroscopic markers (present on the catheter) moved along the catheter shaft but did not separate fully from the catheter and the markers did not remain in the patient (please reference mdr #1721279-2021-00125 which captures the quick-cross catheter in which the fluoroscopic markers moved along the catheter shaft).The team believed the markers moved because they experienced friction while in contact with the distal marker band that was present in the popliteal artery.The quick-cross device was removed, and they continued with the procedure by using a spectranetics 2.0 turbo elite laser atherectomy catheter through the popliteal artery and into the posterior tibial artery.Along the way, the previous 2.3 marker band advanced forward with the laser actively running, and while removing the 2.0 turbo elite device, the 2.3 marker band backed up the artery of the patient, and remained on the tip of the 6f sheath that was also being used in the procedure.The physician inserted a balloon through the 2.3 marker band remaining in the patient and was able to back the marker band, the sheath and the balloon out of the patient, while successfully maintaining guide wire access.The rest of the intervention procedure was completed successfully and the patient survived the procedure with no reported injury.This report is being submitted to capture the 2.3 turbo elite device''s distal marker band that was retained in the patient during the procedure on (b)(6) 2021.On (b)(6) 2021, additional intervention was performed to remove the distal marker band from the patient.
|