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 Problem Difficult or Delayed Positioning (1157)

Patient Problem Alteration In Body Temperature (2682)

Event Date 02/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) (b)(4).(b)(4).Summary of investigational findings: the product was not returned and without the actual complaint device the exact reason for the difficult filter release cannot be determined.Additionally the approach was not reported, but it is assumed that the approach was from femoral vein, as on the image provided the secondary legs bent upwards, as if attempts had been made to pull the pre-exposed filter back into the sheath.Ifu, warning: excessive force should not be used to place the filter.The pre-exposed filter can be advanced, but never pulled back into the sheath.Doing so will damage the shape of the filter.There is no evidence to suggest the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

The filter cannot be released while the filter delivery system was delivered to the target site repetitiously.Then the physician retrieve the filter set to the delivery system and released again, the filter be released successfully this time.Patient outcome: no adverse effect to the patient due to this occurrence.

• 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: 6272093
• MDR Text Key: 65573437
• Report Number: 3002808486-2017-00061
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Date Device Manufactured: 04/09/2014
• 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