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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number N/A
Device Problems Kinked (1339); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation.

 
Event Description

It was reported that during a (b)(6) bird's nest femoral vena cava filter placement procedure, when the filter was advanced through the sheath, the sheath kinked and tore. A second one was opened from a different lot number, it was severely bent and the facility was unable to advance the filter through it. The first two filters had femoral access. The facility opened up a 3rd device and utilized jugular access. They were able to complete the procedure. No unintended section of the device remained inside the patient's body. The product caused or contributed to the need for an additional access site as they switched from femoral to jugular access. No additional adverse effects on the patient were reported due to this occurrence.

 
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Brand NameGIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
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 Key6663653
MDR Text Key78297305
Report Number1820334-2017-01485
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP850049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberBNF-40-PB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/11/2015
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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