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

Model Number G52918

Device Problem Device Handling Problem (3265)

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

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

(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: difficulty using device (dm is to confirm event description).Patient outcome: the patient did not require any additional procedures due to this occurrence.No adverse effects to the patient due to this occurrence.

Manufacturer Narrative

(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: the filter was difficult to go through the sheath diaphragm.It went in with a ¿pop¿.Sheath had slipped back so filter had to be removed.Filter struts were damaged when they looked at it.Patient outcome: no additional procedures were required, no adverse effects on the patient and no part of the device remained inside the patient.No adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: the femoral introducer, the tulip filter, and the dilator placed inside the sheath were returned.Assuming the "sheath diaphragm" was the check-flo valve of the sheath, the dilator was removed in order to investigate the valve, but it was found working as intended.The filter was found damaged with one "blade"/secondary leg bending upwards against the filter hook, thus suggesting attempts had been made to withdraw the femoral introducer with the filter through the valve after "sheath had slipped back so filter had to be removed." however, based on these findings the exact reason, why the filter "went in with a "pop"" in the first place, cannot be determined, but since the "sheath had slipped back so filter had to be removed", it is assumed that the filter was advanced and had to be repositioned, if inadvertently pre-deployed.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL 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: 6405305
• MDR Text Key: 69947815
• Report Number: 3002808486-2017-00825
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529189
• UDI-Public: (01)10827002529189(17)191219(10)E3532996
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G52918
• Device Catalogue Number: IGTCFS-65-1-UNI-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/02/2017
• Device Age: 3 MO
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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: 95 DA