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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG
Device Problems Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Pain (1994); Cramp(s) (2193); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot# is unknown.(b)(4).Investigation is still in progress.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2011".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).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook (b)(4) tulip filter.Expiration date: unknown as lot# is unknown.Mfg date: unknown as lot# is unknown.(b)(4).Information regarding the event has not been provided.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.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 gunther tulip filter on (b)(6) 2011".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).
 
Event Description
This additional information received on 02/08/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the right internal jugular vein due to pulmonary embolism and left lower extremity dvt.Plaintiff is alleging tilt, device unable to be retrieved, cramping, pain.(b)(4).
 
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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
marianne hoey
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6098411
MDR Text Key59717824
Report Number3002808486-2016-01389
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-JUG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date11/07/2016
Date Manufacturer Received02/08/2017
Date Device Manufactured07/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Weight86
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