While preparing material to perform left external and primitive angioplasties with stent(s), the doctor tried to place the dilator inside the sheath.However, the doctor couldn't progress to the end of the sheath and was also unable to "clip" the dilator on the valve of the sheath.The doctor noticed that the dilator extremity was covered by a "strange sticky substance," which looked like glue.He supposed it was inside the sheath and the dilator was covered with the substance upon passing through the sheath.As a result, he was given a different device with the same part and lot number in which he noted presented the same problem- no ability to join the dilator and sheath together to assemble the introducer and a strange sticky substance on the sheath which came out during the attempt to place the dilator inside the sheath.The complainant reported that there was adverse effects on the patient as a result of this product problem.However, this product problem occurred prior to patient contact and no adverse effects were specified.
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