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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
Catalog Number UNKNOWN
Device Problem Material Fragmentation (1261)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative

Brand name: although it was reported that the filter being removed was a gunther tulip ivc filter, we can not supply the full brand name without the access site for the filter placement. Pma/510(k) number = unavailable as the device lot number and catalog number is unknown. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available. Medwatch#: mw5080206. (b)(4).

 
Event Description

The following event was initially reported via hhs/fda sus report reference: mw5080206. During an inferior vena cava (ivc) filter retrieval procedure, it was observed that a strut of the unspecified ivc filter had separated. It was reported that the patient has a history of a distant pulmonary embolism and high blood pressure, and is currently on anticoagulation therapy. For the retrieval procedure, access had been gained via the jugular vein. According to the customer representative, fluoroscopy determined that the legs of the complaint device were embedded in the wall of the patient's ivc, and a "laser" was used to cut them. A cook "tulip retrieval sheath and snare" were used to remove the complaint device, and no resistance was felt during this removal process. However, according to the report, "when the filter was removed and examined, it was noticed that a small piece of one of the struts was missing. [the physician] looked under [fluoroscopy], and the piece appeared embedded in the vessel wall. " the embedded, separated strut was left inside the patient's anatomy. The customer representative reported that the patient's outcome, post-procedure, is "good" and "no issues" have been experienced. The customer representative reported that there is no catalog number or lot number available as it was not recorded during the initial insertion in 2006. The customer representative has confirmed that the complaint device will not be returned to the manufacturer for investigation and, although asked, it is unknown whether imaging, operative reports, pictures, and/or videos will provided.

 
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Brand NameUNKNOWN
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 Key8072457
MDR Text Key127201875
Report Number1820334-2018-03306
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 HEALTH PROFESSIONAL,OTHER,USE
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT 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 Received02/07/2019
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

Patient TREATMENT DATA
Date Received: 11/14/2018 Patient Sequence Number: 1
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