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

Catalog Number IGTCFS-65-UNI

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 02/10/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) k090140.(b)(4).Summary of investigational findings: the used device is returned in original packaging.The filter loaded on the femoral introducer.The secondary filter legs/wires, normally shaped as leaves, are deformed.Furthermore, marks are found on the introducer sheath tip.Both observations strongly indicate, that filter has been advanced out of sheath and afterwards attempted to be retracted into sheath, causing marks on the sheath tip and deformed secondary filter wires/leaves.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: initially, ivc filter system went inside the sheath smoothly.But when the physician tried to reposition and retrieve the filter within the sheath, he was not possible to do so and resulted in deformation of the filter.Hence, the physician withdrew the defective filter and used another ivc filter system.Patient outcome: unknown as information was not provided.

• Brand Name: GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
• 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: 6275485
• MDR Text Key: 65665993
• Report Number: 3002808486-2017-00068
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-UNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2013
• 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: 52