MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "left ij access was used to place filter.The deployment sheath took the anatomy turn but the filter could not take the turn and went out the side of the sheath." information received 01dec2017: filter was never deployed so the deployment part with filter attached was removed from the sheath.A new deployment sheath was used on each attempt.Three attempts with three devices in total ((b)(4)).They were not able to put a filter in the patient that day.Patient was brought back the following day and used a more supportive long sheath and a filter from another company.After dr.Is attributing it to patient anatomy.He wants a more supportive deployment sheath.Patient outcome: no adverse effects reported on the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: investigation is based on event description and returned device.(b)(4) are related.Two jugular introducers, two blue sheaths, and one long dilator were returned in one plastic bag.Consequently, it is unknown, which device relates to which complaint: sheath 1 is severely penetrated approx.24cm from distal tip.The filter is in proper shape and still attached to the introducer.The protection sheath is kinked where the filter hook is attached to the grasping hook.Sheath 2 is severely penetrated approx.33cm from distal tip.The protection sheath is kinked where the filter hook is attached to the grasping hook.The filter is in proper shape, but released, probably because of the kink.Based on these findings the difficulties encountered are probably related to the patient anatomy as reported.Therefore, rep.Follow-up may be relevant to discuss "more supportive deployment sheath".No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that tit did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP 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: 7120307
• MDR Text Key: 95769670
• Report Number: 3002808486-2017-02472
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)200519(10)E3586981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/01/2017
• Device Age: 6 MO
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• 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
• Patient Age: 83 YR
• Patient Weight: 132