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 Difficult or Delayed Positioning (1157)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: as reported to customer relations: " dr.Was using a jugular approach celect platinum.Upon deployment he noticed that the legs and secondary struts didn¿t not open.He was able to retrieve filter from patient and deployed a jugular greenfield filter instead.No injury to patient.Extended procedure time and extra equipment was used (retrieval kit, greenfield filter)." patient outcome: no injury to patient.Extended procedure time and extra equipment was used (retrieval kit, greenfield filter).".

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Only the filter was returned and investigation found it manufactured according to specifications and with diagonals according to specifications.The root cause for the reported deployment issues cannot be determined, but it is previously seen that the filter legs may be somehow obstructed from fully expanding due to e.G.Ivc anatomical conditions, clots or if the filter is not placed in ivc.It is noted that patient did not experience any adverse effects.During the manufacturing/qc processes the spring effect of every filter is 100 % controlled, as they are all deployed after advancement through a testing sheath.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to 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: 7111901
• MDR Text Key: 95624039
• Report Number: 3002808486-2017-02416
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343099
• UDI-Public: (01)10827002343099(17)200810(10)E3618083
• 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
• 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: 12/13/2017
• 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: 11/22/2017
• Device Age: 3 MO
• Date Manufacturer Received: 03/02/2018
• Date Device Manufactured: 08/10/2017
• 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