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 Information (3190)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510k: k171712 investigation is still in progress.

Event Description

Description of event according to initial reporter: "ivc filter had trouble deploying".Additional information provided on 27jun2019: "the device was never deployed in the body.The filter wouldn¿t pass through the delivery system.It got 'stuck'." 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: the filter got stuck and would not pass through the delivery system during the filter placement procedure, so the filter was not deployed in the body.No adverse effects on the patient has been reported due to this occurrence.An introducer dilator, a jugular filter introducer, an introducer sheath and a celect-pt filter was returned for evaluation.Two small dents were found 5.3 and 5.5 mm from the hub at the introducer sheath, which could possibly be caused by an unknown tool.Furthermore, two narrowing were found on the introducer sheath, which could be due to the kinks.It was only possible to advance the introducer 73mm through the sheath, which is where the legs of the filter in the introducer passes through the first narrowing of the sheath.Ifu states that excessive force should not be used, however, the likely cause for the reported event is most likely due to the kinks on the introducer sheath.There are adequate controls in place to ensure the device was 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 the 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: 8774835
• MDR Text Key: 159200190
• Report Number: 3002808486-2019-00950
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)220426(10)E3846833
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3846833
• 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