• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
 
Event Description
It was reported that during an ivc filter removal procedure using a gunther tulip vena cava filter retrieval set, in two separate procedures on the same day, the pin device disconnected from the end of the snare and then the luer lock on the 11 fr sheath separated from the sheath as the physician was pulling.The filters were successfully removed with no adverse effects to the patients.
 
Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, manufacturing instructions, quality control, and visual inspection of the returned device was conducted for this investigation.An investigation of the returned device found the loop wire and its protecting sheath severely damaged in the handle end, but the pin vise was still attached.Approximately 10mm of the blue sheath was compressed approximately 5cm from the tip and the hub was missing.The flare measured to be within specifications.Based on these findings and the information provided, the exact reason for the pin vise to disconnect from the loop wire, cannot be determined, nor can the reason for the hub to separate from the sheath, but it is suggested that the components were exposed to manipulation beyond their intended design during the filter retrieval.It is noted that the filter was successfully removed with no adverse effects to the patient.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.We will continue to monitor for similar complaints, and have notified the appropriate personnel of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6614296
MDR Text Key76740194
Report Number1820334-2017-01089
Device Sequence Number1
Product Code DTK
UDI-Device Identifier00827002132870
UDI-Public(01)00827002132870(17)200331(10)7790804
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 Physician
Type of Report Initial,Followup
Report Date 09/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberGTRS-200-RB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2017
Initial Date FDA Received06/06/2017
Supplement Dates Manufacturer Received09/14/2017
Supplement Dates FDA Received09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-