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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
Model Number G33017
Device Problem Structural Problem (2506)
Patient Problems Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Discomfort (2330); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative

Initial reporter occupation: non-healthcare professional. Investigation: the following allegations have been investigated: organ/vc perforation, limited mobility, swelling, pain, discomfort, tired, weakness, lack of stamina, embarrassment, nerve damage. Investigation is reopened due to additional information provided. The reported allegations have been further investigated based on the information provided to date. Filter interacts with ivc wall, e. G. Penetration/perforation/embedment. This may be either symptomatic or asymptomatic. Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e. G. , a surgical or endovascular procedure in the vicinity of a filter). Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration. Unknown if the reported limited mobility, swelling, pain, discomfort, tired, weakness, lack of stamina, embarrassment, nerve damage are directly related to the filter and unable to identify a corresponding failure mode at this point in time. A total of (b)(4) devices were manufactured in the reported lot. To date, one additional complaint has been reported against this lot. The associated work order was reviewed. No related/relevant notes were documented. The device is manufactured and inspected according to controls. 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. This report includes information known at this time. A follow-up medwatch report will be submitted if additional relevant information becomes available.

 
Event Description

The patient received an implant on (b)(6) 2012 via the right internal jugular vein due to post deep vein thrombosis (dvt). The patient alleges vena cava and organ perforation. The patient further alleges limited mobility, swelling, pain, discomfort, tired, weakness, lack of stamina, embarrassment, and nerve damage. (b)(6) 2017, per a report from computed tomography; ¿ivc filter with: 3mm vertebral and 3mm mesenteric perforation. No tilting, fracture, migration, or stenosis. ¿ (b)(6) 2020, per a report from computed tomography; ¿stable satisfactory position of ivc filter. ¿ original: it is alleged that "[pt] received a gunther tulip filter on 01aug2012. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. ".

 
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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 Key11886807
MDR Text Key263141391
Report Number1820334-2021-01407
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/01/2015
Device MODEL NumberG33017
Device Catalogue NumberIGTCFS-65-JUG
Device LOT Number3404725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/26/2012
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: 05/26/2021 Patient Sequence Number: 1
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