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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC./ WILLIAM COOK EUROPE APS COOK CELECT PLATINUM VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC./ WILLIAM COOK EUROPE APS COOK CELECT PLATINUM VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problems Positioning Problem (3009); Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2015
Event Type  Injury  
Event Description
Ivc filter did not deploy at the correct time causing it to deploy into a lumbar vein. (b)(4).
 
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Brand NameCOOK CELECT PLATINUM VENA CAVA FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC./ WILLIAM COOK EUROPE APS
MDR Report Key8700159
MDR Text Key148212802
Report NumberMW5087373
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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