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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 Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Muscle Weakness (1967); Perforation (2001); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Investigation is reopened due to additional information provided. 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 'subsequent pe, shortness of breath, strength issues'. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Pe is a known risk in relation to filter implant reported in the published scientific literature. Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins. With all filters, there is some risk of further pulmonary embolism. Unknown if the reported shortness of breath and strength issues are directly related to the filter and unable to identify corresponding failure mode(s) at this time. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
 
Manufacturer Narrative
(b)(4). Additional information: investigation: the following allegations have been investigated: bleeding, tilt, organ perforation, embedded. No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56. Update - cinc: product specification spec_91890 gives instructions pertaining to this device. The specification states, "product is manufactured, inspected and packaged by william cook europe (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
Patient alleges bleeding (cat form). As per a ct scan performed on (b)(6) 2017 it is stated, " ivc filter is tilted rightward and posteriorly. Perforation of the anterior strut into the 2nd portion of the duodenum. Perforation of the posterior strut embedded in the t3 vertebral body. Perforation of the medial strut into the aortocaval space. ".
 
Manufacturer Narrative
William cook europe initially reported event under mfr report #3002808486-2017-01909. New information was received identifying that the product was a cook inc. (b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
Patient received an implant on (b)(6) 2010 due to post-op hysterectomy pulmonary embolism, deep vein thrombosis. Patient is alleging subsequent pe, shortness of breath, strength issues without further details.
 
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Brand NameGUNTHER TULIP JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6966079
MDR Text Key252099669
Report Number1820334-2017-03695
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072240
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 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2013
Device Catalogue NumberIGTCFS-65-JUG
Device Lot Number2548846
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 Received04/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2010
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: 10/20/2017 Patient Sequence Number: 1
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