Reportable based on device analysis completed on 05-oct-2018.It was reported that lost image occurred.An 85% stenosed target lesion was located in the mid left anterior descending artery.During a percutaneous coronary intervention procedure, an opticross ic imaging catheter was selected for use.However, during procedure, the image was lost.The procedure was completed using a different device but same model.No patient complications were reported.However, returned device analysis revealed a damage at the lapjoint section (detached).Device evaluated by mfr: the product was returned for analysis.A damaged was observed in the lapjoint section (detached).Impedance testing shows an electrical open at proximal wave form.Full image characterization testing cannot be performed based on the returned condition of the catheter.In order to inspect for imaging core (ic) windup at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly were pulled out from the removed hub.Imaging core windup were encountered in the double heat shrink area of the telescope.Imaging core windup began 2.5 cm from the distal end of the connector shaft.
|