MAUDE Adverse Event Report: WILLIAM COOK EUROPE GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-JP-JUG-TULIP

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: only the filter was returned and investigation found it symmetric and according to specifications.The introducer was not returned and images were not provided, but it is suggested that delivery system/filter was inadvertently pushed when metal knob was pushed for filter release.Package insert: using excessive force when releasing the filter may cause incorrect deployment of the filter.When deploying the filter, as little tilting as possible should be done.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.Manufacturer ref# (b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: only the filter was returned and investigation found it symmetric and according to specifications.The introducer was not returned and images were not provided, but it is suggested that delivery system/filter was inadvertently pushed when metal knob was pushed for filter release.Package insert: using excessive force when releasing the filter may cause incorrect deployment of the filter.When deploying the filter, as little tilting as possible should be done.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: ivc filter placement by right jugular vein was performed.Although the complaint filter was deployed in ivc as labeled way, it was placed with three of the legs of which leaning to one side.As there was a possible risk of migration or decrease in filters' capability of trapping blood clots, it was retrieved out of the body and another filter was placed alternatively.Patient outcome: no adverse effects to the patient.

• Brand Name: GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6265754
• MDR Text Key: 65345574
• Report Number: 3002808486-2017-00016
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037731
• UDI-Public: (01)00827002037731(17)171001(10)E3261236
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JP-JUG-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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 Outcome(s): Required Intervention