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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description of event according to initial reporter: the filter wouldn't deploy from the hook.After some manipulation the filter came off the hook and placement was as intended.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

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is solely based on description of event, no product was returned and no imaging was provided to assist the investigation.Given the limited information provided, it would be inappropriate to speculate at what may or may not have led to the reported filter leg not expanding after deployment.No evidence to suggest that this device was not manufactured according to specifications.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: 6430842
• MDR Text Key: 70775516
• Report Number: 3002808486-2017-00864
• Device Sequence Number: 1
• Product Code: DTK
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2017

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 Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/10/2017
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 08/23/2017
• 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