MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

Device Problems Break (1069); Failure to Unfold or Unwrap (1669); Difficult or Delayed Activation (2577)

Patient Problem No Information (3190)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "they went to place the device femorally.They got it into position.They advanced it to the tactile bump.They went to deploy.As they were pinning and pulling / unsheathing and locking it into position, the handle part would spin around, which it should not have done.When the doctor went to push the grey button to deploy, the grey button snapped and broke.The filter was in the patient and the legs did not open up.They spent 3.5 hours.First they tried to retrieve and were unsuccessful.They used several catheters and snares to try to open up each of the legs individually.They were successful with that so the filter stayed in the patient and did not migrate.The placement was successful after 5 hours of working on it and trying to open up the filter." patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).Correction in patient outcome.G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Summary of investigational findings: investigation is based on event description and returned device.It was reported that, as they were pinning and pulling / unsheathing and locking the filter into position, the handle part would spin around, which it should not have done.When the doctor went to push the grey button to deploy, the grey button snapped and broke.The filter was in the patient and the legs did not open up.They spent 3.5 hours.First they tried to retrieve and were unsuccessful.They used several catheters and snares to try to open up each of the legs individually.They were successful with that so the filter stayed in the patient and did not migrate.The placement was successful after 5 hours of working on it.The jugular introducer, the long dilator, the blue sheath, and the femoral introducer were returned.The od of the cup on the used femoral introducer was according to specifications.The grey release button was pressed, but not broken as reported and the handle could be attached to the sheath as intended.It is unknown, what is ment by "the handle part would spin around, which it should not have done", as the introducer and the sheath could be attached, but are not supposed to be fixated.The tip of the blue sheath was is according to specifications, too.During investigation the system worked as intended and the introducer could be advanced through the sheath with a slight resistance.The device history record for the celect-pt filter was investigated and appears to be complete and correct, with no evidence to suggest that the filter was not manufactured according to specification.No imaging was provided and based on the returned components the exact reason, why the filter would not expand cannot be determined.However, it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.It is noted that the filter placement was prolonged, but successful and that no adverse effects to the patient were reported.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.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.

Event Description

Patient outcome: add.Venogram to ensure correct placement.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7994493
• MDR Text Key: 124978505
• Report Number: 3002808486-2018-01232
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)210725(10)E3754002
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3754002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Distributor Facility Aware Date: 10/04/2018
• Device Age: 2 MO
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1