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

Model Number G34309

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: non-healthcare professional.Name and address for importer site: (b)(4).Type of investigation not yet determined.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "the filter would not deploy when the button was pressed.They retracted it back into the sheath.The filter then self-deployed unexpectedly in the wrong area.It had to be retrieved with a gunther tulip retrieval set.It was successfully retrieved.They then successfully completed the procedure with another filter." 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

Exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref#: (b)(4).Mfr site: name and address for importer site: (b)(4).Ec conclusion code: 4315 - cause not established.Summary of investigational findings: investigation is based on event description and returned device.A jugular introducer and a gtrs with looped filter were returned.During investigation the filter was removed from the gtrs loop and cleaned.Afterwards the correctly shaped grasping hook of the jugular introducer could easily grasp and hold on to the filter and when pressing the release button the filter released as intended.Based on these findings the exact reason, why the filter deployed unexpectedly in a wrong area and why it would not release in the first place cannot determined.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it 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

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 JUGULAR 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: 7730772
• MDR Text Key: 115351284
• Report Number: 3002808486-2018-00830
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)210406(10)E3710521
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2021
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Device Lot Number: E3710521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Distributor Facility Aware Date: 07/05/2018
• Device Age: 3 MO
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR