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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS COOK CELECT FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE APS COOK CELECT FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G48373
Device Problems Entrapment of Device (1212); Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/31/2017
Event Type  Malfunction  
Event Description

Cook celect ivc filter model # g48373 was implanted about 5 years ago. It is our practice to remove ivc filters as soon as possible (this is the manufacturer recommendation also). However, this patient did not respond to follow up. The device remained in place longer than planned. The device was not removed until last month. At which time, a portion of the filter was embedded in the lumbar spine. The embedded portion is retained and the rest of the device removed.

 
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Brand NameCOOK CELECT
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE APS
750 daniels way
bloomington IN 47404
MDR Report Key6518024
MDR Text Key73586511
Report Number6518024
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberG48373
Device Catalogue NumberIGTCFS-65-FEM-CELECT-PERM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2017
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer04/17/2017
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

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