Two.018" guidewires were returned for evaluation.The wire indicated to be for this complaint has a knot at the distal end.The other guidewire appears to have looped back around itself and formed a knot on the distal end.Both guidewires have a great deal of tissue entangled in the knotted area.After decontamination a large portion of the tissue was removed but it was not possible to remove all of it.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A root cause cannot be determined but is not likely manufacture related.A possible cause of the knotted tip could be a back-and-forth (in and out) motion during insertion.This can cause the wire to fold back on itself and result in a knotted tip.This may also cause the wire to be difficult to remove, resulting in applying more forces than the device is designed to withstand in order to remove it.The instructions for use (ifu) contains the following cautions: *do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath/dilator and guidewire must be removed together.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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