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

Catalog Number IGTCFS-65-JP-FEM-TULIP

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Hematoma (1884)

Event Date 01/15/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-fem-tulip.Similar to device under 510(k) k090140.Summary of investigational findings: the images shows that the filter has expanded and positioned well.Also it appears that the filter is in a normal configuration.However, the secondary legs is curled, due to the attempt of retract the filter into the sheath.The specific package insert states that any attempt to reload (resheath) the filter may damage the introducer or the filter.No evidence to suggest that 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: the physician inserted the delivery system from the right femoral and attempted to release the filter in the ivc but failed due to poor understanding how to release.The filter deformed when he pulled it to be in the sheath to retrieve.He again operated the system to release the filter, then the filter was released in the ivc.The patient is closely followed.Additional information received on (b)(4) 2013: on (b)(6) 2013, additional procedure to retrieve the filter using gtrs-200-rb was performed, but the filter could not be retrieved since the physician could not capture the filter hook.Hematoma like thing in ivc was confirmed.Patient outcome: the patient is closely followed but his condition is unknown as not provided by reporter.

• Brand Name: GÜNTHER TULIP VENA CAVA FEMORAL 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: 6265979
• MDR Text Key: 65349324
• Report Number: 3002808486-2017-00011
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)150621(10)E2937521
• 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: 01/17/2013

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-FEM-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2013
• Date Device Manufactured: 06/21/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14