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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Blood Loss (2597); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Additional information: 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, "ivc perforation, tilt, device unable to be retrieved, pain in back, side and legs, bleeding, and anxiety. " cook will reopen its investigation if further information is received. Vena cava wall perforation is a known potential complication of vena cava filters. Both symptomatic and asymptomatic events have been reported. Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e. G. , a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.
 
Manufacturer Narrative
(b)(4). Evaluation- 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
It is alleged that "[pt] received a bird¿s nest filter on (b)(6) 2004 at (b)(6). It is alleged that patient was injured without further explanation. Patient is seeking punitive damages. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion. (b)(4).
 
Event Description
This additional information received on 3/1/2017 as follows: the patient allegedly received device implant via right femoral vein on (b)(6) 2004 due to pulmonary embolus. The patient alleges the device tilt, that the device is unable to be retrieved and has experienced bleeding since the placement of the device.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
(b)(4). Name and address for importer site: (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information was received on 04/24/2017 as follows: the plaintiff allegedly received the device implant on (b)(6) 2004 via the femoral vein due to pe and dvt. The plaintiff alleges ivc perforation, tilt, device unable to be retrieved, pain in back, side and legs, bleeding, and anxiety.
 
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Brand NameUNKNOWN
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
8128294891
MDR Report Key6277378
MDR Text Key196056345
Report Number1820334-2017-00089
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
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 Received09/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/25/2017 Patient Sequence Number: 1
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