D4: the device lot was updated to the lot found on the returned label.This supplemental report is being submitted to provide the results of the manufacturer's investigation.An evaluation of the device, a review of the device history record (dhr), and a review of the instructions for use (ifu) was conducted as part of the investigation.The device was returned with the original packaging.The device was coiled in the original protective hoop.The thumb advance inducer was not returned.The guidewire was inspected and there was damage on the hydrophilic tip.The rest of the guidewire did not show any visible damage.The damage on the tip was a small piece of the hydrophilic coating missing.The inner wire of the tip was not exposed.The missing piece was near the base of the coating, where the floppy tip connects to the main guidewire.The hydrophilic coating had some cracking throughout the whole tip.The damage of the coating was confirmed, however it is very unlikely that this coating was broken in multiple pieces.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause of the damage was unable to be confirmed.A possible cause is sharp bending of the device causing this damage.The ifu contains the following statements: "the tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument." olympus will continue to monitor for similar events.
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