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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 DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number GTRS-200-RB
Device Problems Bent (1059); Material Separation (1562); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

It was reported that a gunther tulip vena cava filter retrieval set was used to retrieve a celect platinum vena cava filter from an (b)(6) female patient. The filter was noted to have been implanted in the patient on (b)(6) 2017. The filter was able to be hooked; however, while attempting to advance the sheath over the filter with the coaxial sheath set, the filter hook bent over the snare (medwatch reference number will be provided when available) and the 11 fr sheath separated from its hub simultaneously. It was noted the tips of both sheaths were jagged/ bent/ cut (refer to medwatch 1820334-2017-04626). The physician attempted to remove the gunther tulip vena cava filter retrieval set to exchange it with a new set; however, the snare was unable to be removed due to the bent filter hook, and the set had to be completely dismantled to remove all of the parts. The snare was left inside of the patient's anatomy at this point. Another retrieval set was opened and flushed; however when the physician pulled on the hub, it separated from the sheath and was therefore unable to be used to continue the procedure (refer to medwatch 1820334-2017-04627). This did not make patient contact. Another manufacturer's sheath was utilized to successfully complete the filter retrieval. A section of the devices used did not remain inside the patient¿s anatomy. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient was noted to experience slightly-above normal blood loss due to the quantity of devices changed out, however there was no concern from the physician, and no additional intervention was required. A normal post-venogram was observed.

 
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Brand NameGUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Type of DeviceDTK 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 Key7151483
MDR Text Key96015614
Report Number1820334-2017-04627
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK073374
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,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberGTRS-200-RB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated By Manufacturer? Yes
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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