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 Bent (1059)

Patient Problems Discomfort (2330); Valvular Stenosis (2697)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-1-jug-celect-pt.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "an (b)(6) female had a cook celect platinum navalign jugular vena cava filter set, g34309, prophylactically implanted on (b)(6) 2017.Patient underwent a filter retrieval procedure on (b)(6) 2017.For the removal procedure, the gunther tulip vena cava filter retrieval set was used (g13287, lot# 8258931).The retrieval set was inserted and hooked on the filter per usual.While attempting to over sheath the filter with the coaxial sheath set, the filter hook bent over the snare ((b)(4)) and the 11fr sheath separated from its hub ((b)(4)), simultaneously.At this point, the physician was going to un-snare the filter and remove all parts of the kit and start with a new retrieval set but as the filter hook was bent over the snare, the snare could not be removed.The physician had to completely dismantle the set in order to remove all parts of the gtrs leaving only the snare in the patient.Another retrieval set (g13287, lot# unknown) was pulled.The device was opened, flushed and when the physician pulled on the hub, the sheath became detached just as it did with the first kit ((b)(4)) and therefore could not be used to continue the procedure.Since the only large cook sheaths available at the hospital were too short, a device from another manufacturer was opened and used to continue and complete the procedure.The sheath was able to collapse the filter without incident and was therefore removed from the patient.All primary and secondary struts of the filter were still attached.Other than some discomfort and just slightly above normal blood loss (from changing out so many devices due to difficulties), no concern to the physician and no transfusion.It was noted the tips of both sheaths of the first gtrs (lot# 8258931) were damaged; jagged, bent, cut.There was nothing left inside of the patient, no filter or sheath fracture, no significant changes, no patient harm, and a normal post-venogram was seen.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.(b)(4).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on event description and returned product.The filter and the loop wire of the cook retrieval device were returned; as reported the loop wire stuck to the bent hook and could not be removed.No imaging was provided and without evidence of filter alignment and/or filter embedment, the exact reason why "the filter hook bent over the snare" when "attempting to over sheath the filter with the coaxial sheath set" approx.Two months after filter placement cannot be determined, but strong manipulation during the retrieval attempt may have caused it.It is noted that the filter was retrieved by use of a non cook device and except from some discomfort and "just slightly above normal blood loss", the retrieval attempt caused no harm the patient.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will monitor for similar events.

• 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
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7166943
• MDR Text Key: 97501984
• Report Number: 3002808486-2018-00038
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)190614(10)E3461285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34309
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/18/2017
• Device Age: 18 MO
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR