The device was not returned for evaluation.Device history record (dhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.In this case it is possible that the guidewire being used became damaged, the distal marker band on the catheter became damaged, or the guidewire was inadequately lubricated (wet) affected the ability to remove the catheter; however, this could not be confirmed.Based on the reported information and results of the complaint investigation there is no indication that the reported difficulty to remove and difficulty to insert are related to a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: d9 - device available for evaluation updated from ¿yes¿ to ¿no¿ correction: h6 - health effect - impact code 2645 was removed and code 2199 was added.
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