The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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During preparation for a medical procedure, the physician found that the tip of the lantern delivery microcatheter (lantern) had irregular shape upon removal of the packaging mandrel.The reported issue was found prior to use.Therefore, the lantern was not used in the procedure.The procedure was completed using a new lantern.
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