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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
The device was implanted inside of the patient in 2002. Investigation - evaluation: a review of the documentation, and specifications was conducted during the investigation. The complaint device was not returned; therefore no physical examination could be performed. No images were provided for review. There is no available information regarding patient anatomy or if patient had megacava. There is no information regarding placement of the device or if excessive force was used or if the sheath was advanced over the anchors. There is no information regarding the pressure or flow rate used for the power injector. However, a document-based investigation was performed. There is no evidence to suggest the finished product was not made to specifications. Review of the device history record of the finished product was unable to be performed as the lot number for the device was not available. A complaint history search was also unable to be performed due to the lack of a lot number. Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position. Among other causes, filter fracture may be associated with a filter leg perforating the inferior vena cava (ivc), a filter leg being caught in a side branch (e. G. Renal vein), 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. Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined. Per the risk assessment, no further action is required. Monitoring will continue to be performed for similar complaints.
Manufacturer Narrative
(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.
Event Description
It was reported that two of the gunther tulip vena cava filter fine wires were broken, and a fragment of approximately one (1) centimeter (cm) of fine wire had embolized to the right upper lobe (rul) of the patient's lung. The filter was able to be removed; however, some extravascular wire was left inside of the patient's anatomy. The patient was noted to be returning for retrieval of the rul wire fragment. The user facility medwatch and additional information pertaining to event details has been requested, but is not available at this time.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7135345
MDR Text Key266767799
Report Number1820334-2017-04358
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
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: 12/20/2017 Patient Sequence Number: 1