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

Catalog Number IGTCFS-65-2-JUG-CELECT-PT

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k)/pma k121629.Investigation is still in progress.

Event Description

Description of event according to initial reporter: "we just had difficulty releasing a cp filter and retrieving the system".As per complaint form: when the operating physician had difficulty retrieving the delivery device he called in another physician for his thoughts.The filter deployed without incident, but when the physicians looked at screening images (high definition fluoroscopy), they noticed that the hook on the delivery system was hooked onto the vein.After much maneuvering the operating physician managed to release the hook.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.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description only.It was reported that the filter deployed without incident but the hook on the delivery system cached the vein.The hook released after much maneuvering and there was no harm to the patient.No product was returned and no imaging was provided.Therefore, based on limited information received it is not possible to conclude why the hook on the delivery system became lodged into the vein after filter release.However, it is noted that 'after much maneuvering' the physician managed to release the hook and that the patient did not experience any adverse effects due to this occurrence.No evidence to suggest the product was not manufactured according to current 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.

• 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: 8581679
• MDR Text Key: 145642475
• Report Number: 3002808486-2019-00563
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343105
• UDI-Public: (01)10827002343105(17)220205(10)E3820496
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Catalogue Number: IGTCFS-65-2-JUG-CELECT-PT
• Device Lot Number: E3820496
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/11/2019
• Device Age: 2 MO
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1