Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = line 2: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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As reported, the polymer jacket separated from the tip of the hiwire nitinol hydrophilic wire guide, prior to an unknown procedure.The coating was activated by injecting saline.The damage was observed before the wire guide was removed from the holder.The procedure was complete by using another same device.The complaint device did not make contact with the patient.The patient did not experience any adverse effects due to this occurrence.
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