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

Catalog Number IGTCFS-65-JUG

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Headache (1880); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

Correction(s): from product problem to adverse event. From malfunction to serious injury. Blank fields on this form indicate the information is unknown, unavailable or unchanged. It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿bleeding, headache". Unknown if the reported "bleeding, headache" is directly related to the filter and unable to identify a corresponding failure mode at this point in time. 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

Initial mdr was submitted by william cook (b)(4) under reference # 3002808486-2016-00166. Additional information provided on 05/30/2016 determined this device was manufactured by cinc. (b)(4). Evaluation- the device was not returned to assist with the investigation. No information regarding the event has been provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on alleged injuries. No notes of relevance on found on the work order, nor on filter lots. No other complaints received under the same lot. There is no evidence to suggest the device was not manufactured to specifications. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2010 at (b)(6)". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4). Evaluation: the device was not returned to assist with the investigation. No information regarding the event has been provided. We have investigated based on the information received to date, and are closing the report until further information is received for investigation. Impossible to comment on alleged injuries. No notes of relevance on found on the work order, nor on filter lots. No other complaints received under the same lot. There is no evidence to suggest the device was not manufactured to specifications. We have notified appropriate personnel and will continue to monitor for similar events. If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2010 at (b)(6)". Patient outcome: it is alleged that [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(b)(4). Corrected data based on new information received: adverse event to product malfunction, manufacturer report # updated to 1820334-2016-00467 per previous follow-up, serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 04/22/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the right jugular vein due to recurrent dvt and pe while on therapeutic coumadin. Plaintiff is alleging bleeding and headache. Patient alleges successful retrieval on (b)(6) 2016.

• Brand Name: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5837248
• MDR Text Key: 251894139
• Report Number: 1820334-2016-00467
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• 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
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 03/15/2016
• Device Age: 56 MO
• Event Location: No Information
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/23/2011
• 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: 08/01/2016 Patient Sequence Number: 1