Event summary: the patient data files showed at least six injections were performed with catheter 2af283/31317 on the date of the event, system notice (b)(4) was received indicating that the safety system detected a compromised outer vacuum was triggered on application number six.Visual inspection of sheath, 4fc12/ 64100, showed the shaft was kinked and folded from the tip to 2.77 inches in proximal from the tip.In conclusion, the reported system notice (b)(4) was received indicating that ¿the safety system detected a compromised outer vacuum¿ issue has been confirmed through data analysis.The sheath failed the product inspection due to shaft kink.If information is provided in the future, a supplemental report will be issued.
|