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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

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COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET Back to Search Results
Model Number G13287
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  Malfunction  
Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable. Common name & product code = dtk filter, intravascular, cardiovascular. Occupation = unknown. Pma/510(k) number = k073374. Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

As initially reported, during retrieval of an unknown filter using a gunther tulip vena cava filter retrieval set, the filter collapsed but was difficult to disengage from the caval wall. The filter was ultimately removed successfully with the complaint device. Upon evaluation of the returned device on 18sep2019, a split was found on the distal end of the blue retrieval sheath. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
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 Key9962119
MDR Text Key190947534
Report Number1820334-2020-00822
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,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG13287
Device Catalogue NumberGTRS-200-RB
Device LOT Number9585063
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/28/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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