MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Additional information: a review of the complaint history and specifications was conducted during the investigation. Investigation is based on description of event. No product was returned and no imaging was provided. Filter retrieval is occasionally difficult. This is well-known from published scientific literature where filter retrievals are referred to as simple vs. Complex. Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.

Manufacturer Narrative

(b)(4). The event is currently under investigation.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2002 at (b)(6). ¿ it is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.

Event Description

It is alleged that the ¿patient received a cook gunther tulip on (b)(6) 2002 at (b)(6). ¿ it is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

The 510(k) - k032426. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 02/11/2017 as follows: patient is alleging that device is unable to be retrieved.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6149085
• MDR Text Key: 130359988
• Report Number: 1820334-2016-01412
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-FEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/06/2016 Patient Sequence Number: 1