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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 Failure to Align (2522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/13/2010
Event Type  Malfunction  
Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown. Occupation: attorney. Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure to place an inferior vena cava filter in a patient undergoing gastric bypass surgery, a cook tulip inferior vena cava filter tilted upon deployment of the device. Lidocaine was used for local anesthetic. The patient was placed under conscious sedation, using fentanyl and versed, for one hour. Vital signs remained stable throughout the procedure. Access was obtained in the right internal jugular vein, using an 18 gauge needle and ultrasound guidance. An unknown 0. 035 inch wire and unknown 8. 5 french delivery sheath were advanced to the inferior vena cava. Imaging demonstrated normal anatomy. The tulip filter was then deployed. Reportedly, the filter tilted "significantly" upon deployment, with the filter hook abutting the caval wall. The user decided to remove the filter and the delivery set was initially exchanged for an unknown loop snare; however, the tip of the filter would not engage the loop snare, despite multiple attempts. The snare was then exchanged for a cook retrieval set and the filter was removed without difficulty. Another cook filter was then placed, which was later found to have tilted and perforated the vena cava. The complaint on the second filter has been previously reported under reference number (b)(4).

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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
MDR Report Key10349765
MDR Text Key207542029
Report Number1820334-2020-01398
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 OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial