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

Model Number G34505

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: ir supervisor.Pma/510(k) k171712.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a female patient, unknown age, underwent a celect filter placement in ivc in which the cook celect platinum navalign uniset vena cava set, g34505, was used.While the tech was prepping filter and loading it on jugular deliver set, he [the tech] noticed that the push button to move hook was acting like it was sticking, but still working.He let the physician know before being use.Physician went ahead with filter placement and when he went to release filter off delivery device it stuck on end and would not come off.They [the tech & physician] forcefully got it to come off but that created tilt in filter placement which then they needed to retrieve the filter and replace it in a straight manner.So they use a cook retrieval set and snared the filter and repositioned it straight.They also had difficulty getting it to sit straight with snare set.They were able to eventually get the filter to sit straight with anatomy and finish procedure.Additional information received 15jul2019: the physician used a second filter after the first was removed.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.

Manufacturer Narrative

Manufacturers ref (b)(4).Summary of investigational findings: when the technician was prepping the filter and loading it on the jugular delivery set, it was noticed that the release button was acting like it was jamming, but still working.The technician informed the physician before it was used in the procedure, however filter placement procedure was proceeded.When the physician went to release the filter, it stuck and would not come off.The user got the filter released with force, but the filter was placed in a tilted position.The user had difficulty in straightening the filter with a retrieval set, and the filter was therefore retrieved.A new filter was used to finish the procedure.No adverse effects on the patient has been reported due to this occurrence.A jugular introducer, an introducer sheath and e celect-pt filter was returned for evaluation.The released button was stuck in a not fully released position and the grasping hook was still inside the introducer.However, the release mechanism was fully functional and the grasping hook was advanced, after soaking the introducer for a short period of time.The introducer did also have a severe kink.Ifu states that the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.The user discovered the failure prior to patient use, but proceeded with the device.Furthermore, ifu states that excessive force should not be used, however, the filter got released with force.Lastly, when the filter is ready for release, the red safety button is first pushed, followed by pushing the release button completely to ensure proper release of the filter.It is not clear in the event description whether the safety button was pushed, if the release button was pushed completely or if there was any clinical setting that could have had an impact.It is therefore unknown why the user felt difficulty in releasing the filter and the likely cause for the reported event cannot be established.There are adequate controls in place to ensure that this type of device is manufactured to specifications.It was assessed that because any discovered non-conformances were properly dispositioned before qc release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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

No additional information regarding the patient and/or event has been received since previous medwatch report was sent.

• 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: 8858792
• MDR Text Key: 158991809
• Report Number: 3002808486-2019-01108
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220301(10)E3827372
• Combination Product (y/n): N
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3827372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention