The complaint was forwarded to the manufacturer and investigated.The device history record (dhr) has been reviewed and showed no deviations.Since neither samples, nor film or picture material were available for an investigation, but only the present description and the production documents did not show any deviations, the evaluation was concluded on the basis of the information available.The cause of the defect cannot be determined.After production, the system was 100% checked by the employees and qa and was in compliance with the specification.Complaint determined reportable on 01/30/2020.
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Physician performed a standard pda procedure, measured and decided to use a 5x4 nit-occlud.Physician followed all ifu instructions before release and after deployment saw that there was still residual flow through the ductus.After waiting an additional five minutes, there was still flow.Physician went up with a catheter to see if an additional coil could be put in to stop the flow.While working with the catheter around the nit-occlud, it became dislodged and went into the tricuspid valve.When the coil was retrieved and out of the body, the coil was coming off of the inner core wire.This may have happened in the snaring process.Physician used a snare to get it out and then used an amplatzer to close the pda.Measured ductus size (mm): aortic 3.2, pulmonary 1.3, length 3.9.Procedure duration: 128 minutes.Pda access: venous and aortal.A cook 7f introducer sheath was used.Heparin (systemic) iu/kg: 1500 units - don't give heparin but because of the issue they did.They use a manifold bag.The physician did not notice high resistance during forwarding or retrieval of the system into the implantation catheter.Curvature of implantation catheter in the vessel was straight.The physician did no notice a gap between pusher and coil prior to release.The physician moved the rotation screw 8-15 revolutions forward for release.
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