Description of event according to initial reporter: "they were performing a jugular approach on a patient to place the ivc filter, and the patient was complaining of pain.The ivc filter was in the sheath when the pain began.The physician felt high resistance, and decided to pull the sheath out of patient.The sheath was split/fractured down the side of the sheath, and the filter was exposed.They opened another celect and placed it with no problem." patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
|
Exemption number e2016032.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Only the blue introducer sheath was returned and an investigation found a 15mm penetration approx.20cm from the hub at the proximal end.The penetration was probably caused by a filter leg and the exact reason for this to occur cannot be determined, but the reported high resistance during the filter advancement may have caused it.Under normal conditions the introducer sheath is strong enough to accomplish the procedure, but it may kink if excessive force is used to advance it through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.No evidence to suggest device was not manufactured according to specifications and no evidence to suggest that it did not perform as intended.Cook medical will continue to monitor for similar events.
|