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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

William cook (b)(4) initially reported event under mfr report # 3002808486-2016-00325.New information was received identifying that the product was a cook inc.Manufactured device.An updated emdr report was submitted under cook inc.Mfr report # 1820334-2016-00677, follow up # 1.This was in reference to william cook (b)(4) mfr report # 3002808486-2016-00325.However, the initial for mfr report # 1820334-2016-00677 had already been used on a different complaint.Cook is now submitting an initial report under mfr report #1820334-2016-01610 to correct this issue.Blank fields on this form indicate the information is unknown, unavailable or unchanged.(b)(4).Evaluation- 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 in 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) 2012 at (b)(6) in (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.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6175205
• MDR Text Key: 62418545
• Report Number: 1820334-2016-01610
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002330174
• UDI-Public: (01)10827002330174(17)141101(10)2877397
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IGTCFS-65-JUG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2016
• Date Device Manufactured: 12/01/2011
• 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): Other