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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-FEM
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Pain (1994); Irregular Pulse (2469); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Catalog#: unknown but referred to as a gunther tulip filter.(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) 2010." 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).Catalog#: unknown but referred to as a gunther tulip filter.Expiration date: unknown as lot# is unknown.Mfg date: unknown as lot# is unknown.(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 receiving warranting supplementation in accordance with 21 c.F.R.803.56.
 
Event Description
Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010." 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 02/06/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2010 via the left common femoral vein due to deep vein thrombosis.Plaintiff alleges attempted retrieval on (b)(6) 2011.Plaintiff is alleging device unable to be retrieved, pain, and occasional irregular heartbeat without further details.(b)(4).
 
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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 Contact
marianne hoey
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6212088
MDR Text Key63471768
Report Number3002808486-2016-01567
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043509
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 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberIGTCFS-65-FEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/06/2017
Date Device Manufactured07/16/2010
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; Other;
Patient Weight59
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