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 Premature Activation (1484); Device Handling Problem (3265)

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

Event Date 06/10/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-jp-fem-tulip.Pma 510(k): similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: since no product or images are received, evaluation is based on the description solely.Unable to determine exact reason for filter to jump.It is stated that "when deploying the filter, the user pushed the inner catheter by mistake and the filter jumped and placed at unexpected site".It is therefore presumed that physician has pushed the filter delivery catheter forward instead of withdraw the sheath and tuohy-borst sidearm adapter to the filter delivery catheter.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: when deploying the filter, the user pushed the inner catheter by mistake and the filter jumped and placed at unexpected site.He inserted a sheath of günther tulip vena cava femoral approach from the jugular and inserted a goose neck snare to fix the filter position.The position was fixed successfully and the procedure was completed.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

• 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: 6299484
• MDR Text Key: 66433442
• Report Number: 3002808486-2017-00172
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002037755
• UDI-Public: (01)00827002037755(17)140701(10)E2767294
• 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: 06/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/12/2013
• Date Device Manufactured: 07/01/2011
• 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