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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems No Information (3190); Insufficient Information (4580)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative

Manufacturer ref# (b)(4). Occupation: non-healthcare professional, purchaser. Pma/510(k): k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: the feet of the filter are in the right common iliac. The filter was accidentally deployed that way on (b)(6) 2020. They are intending to retrieve the filter. The anatomical location of the filter deployment was top in the distal ivc with the feet landing in the right proximal common iliac. The orientation and tilt of the filter at implant is originally unknown but it is presently tilted. Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key11336848
MDR Text Key232323350
Report Number3002808486-2021-00127
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/17/2021 Patient Sequence Number: 1
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