MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL & JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-UNI-CELECT

Device Problem Positioning Failure (1158)

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

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog# igtcfs-65-uni-celect.(b)(4), similar to device under 510(k) k090140.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: insert filter, filter didn`t deploy.Additional information received 11oct2017: the filter introduced by femoral approach and it retrieved with other (not cook) snare and a catheter.Patient outcome: another device was used.No adverse effects to the patient.

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 device.The complete device was returned in original tray, but with separated filter.Three pair of secondary legs were crossed.The handle of the introducer was slightly bent, but despite remnants of blood on the piston and the cup, the femoral introducer worked as intended and no damages were noted.Based on very limited information provided it cannot be determined if the filter would not release or if it would not expand.However, it is assumed that the filter would not release from the femoral introducer, but based on the findings the exact reason for this to occur cannot be 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.

• Brand Name: COOK CELECT FEMORAL & 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: 7002534
• MDR Text Key: 92165593
• Report Number: 3002808486-2017-02178
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002456228
• UDI-Public: (01)00827002456228(17)180413(10)E3438813
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI-CELECT
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/11/2017
• Device Age: 16 MO
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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