Catalog Number IGTCFS-65-1-JUG-CELECT-PT |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 10/01/2015 |
Event Type
No Answer Provided
|
Manufacturer Narrative
|
(b)(4).Catalog # igtcfs-65-1-jug-celect-pt.Investigation is still in progress.
|
|
Event Description
|
Description according to complainant: during an ivc filter placement with jugular approach procedure, the primary legs on the ivc filter would not open.The physician released the filter instead of re-sheathing it and getting a new one.A gunther tulip retrieval set was used to retrieve the defective filter then placed a new jug celect platinum with no issues.Patient outcome: the patient did not experience any adverse effects due to this occurrence.
|
|
Manufacturer Narrative
|
(b)(4).Catalog # igtcfs-65-1-jug-celect-pt.Summary of investigational findings: retrieval system was returned with the filter attached.No error was found on the filter.No imaging was provided and the root cause cannot be determined based on the available information and the returned product.However, the filter legs may have been somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if not placed in ivc.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.(b)(4).Catalog # igtcfs-65-1-jug-celect-pt.Summary of investigational findings: retrieval system was returned with the filter attached.No error was found on the filter.No imaging was provided and the root cause cannot be determined based on the available information and the returned product.However, the filter legs may have been somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if not placed in ivc.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
|
|
Event Description
|
Description according to complainant: during an ivc filter placement with jugular approach procedure, the primary legs on the ivc filter would not open.The physician released the filter instead of re-sheathing it and getting a new one.A gunther tulip retrieval set was used to retrieve the defective filter then placed a new jug celect platinum with no issues.Patient outcome: the patient did not experience any adverse effects due to this occurrence.
|
|
Search Alerts/Recalls
|