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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
Model Number N/A
Device Problems Difficult to Remove (1528); Insufficient Information (3190)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombus (2101); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Manufacturer Narrative
Additional information: this report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
Pt allegedly received an implant on (b)(6) 2007 via the right common femoral vein due to prior to gastric bypass surgery. Pt is alleging occlusion, embedded and the device is unable to be retrieved. The pt further alleges blood clots, shortness of breath, post implant dvt and pain. Retrieval was attempted on (b)(6) 2007.
 
Event Description
This additional information received on 05/jan/2018 as follows: patient received an implant on (b)(6) 2007 via the right common femoral vein due to prior to gastric bypass surgery. Patient is alleging blood clots, shortness of breath and pain due to the device. Retrieval was attempted on (b)(6) 2007.
 
Manufacturer Narrative
(b)(4) corrected data based on new information received: adverse event to product problem. Serious injury to malfunction. Blank fields on this form indicate the information is unknown or unavailable, or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that the plaintiff received a gunther tulip filter implanted on (b)(6) 2007. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameGUNTHER TULIP FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK 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 Key7152003
MDR Text Key254620731
Report Number1820334-2017-04673
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,Followup
Report Date 03/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberIGTCFS-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 Received03/12/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/09/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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