Section b1: adverse event: corrected: no adverse event section b2: outcomes attributed to ae: corrected: no other serious (important medical events), section b5: updated information.Section h1: type of reportable event - corrected: no serious injury section h6: patient code grid: corrected: from "injury" to "no consequences or impact to patient" section h3: device evaluated by mfg/ summary attached ¿updated the device history record (dhr) could not be reviewed because the lot number was not reported.However, due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Analysis of the device revealed that the coil delivery wire was kinked; likely due to handling.The main coil was previously detached.Analysis of the inzone data shows high impedance conditions which may be an indication of the presence of contrast or embolus to the detachment zone preventing current flow and failure to detach.An assignable cause of procedural factors will be assigned to the reported ¿main coil failed/unable to detach¿ as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu (directions for use) but due to procedural and/or anatomical factors during use, the product performance was limited.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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