Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.The devices were not returned for analysis.Review of the lot history records and similar incident review could not be conducted because the part and lot numbers were not provided.Due to the limited information available, the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other reportable events referenced in the pmcf are filed under separate medwatch report numbers.Attachment: post-market clinical follow-up evaluation report accessories and indeflators.
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This is filed to report the potential device malfunctions related to the guide wire introducer.It was reported through the post-market clinical follow-up evaluation (pmcf) report, that the guide wire introducer may be related to the adverse patient effects of air embolism and the device malfunctions of difficult insertion, difficult removal and kink.Details are listed in the attached pmcf, titled post-market clinical follow-up evaluation report accessories and indeflators.Please see pmcf for specific information.
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