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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 Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Manufacturers ref# (b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog# is unknown but referred to as cook gunther tulip filter similar to device under pma/510(k) k172557. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: physician inserted tulip filter on the jugular deployment system into the sheath that was already inserted in the jugular vein. While physician was advancing the filter he began to feel resistance and stopped advancing. The filter struts had punctured the delivery sheath and protruded out of the sheath into the vessel of the patient. The rest of the procedure was successful. Patient outcome: no adverse events were reported.

 
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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)
COOK MEDICAL
sandet 6, dk-4632
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov DK-46-32
DA   DK-4632
30632506
MDR Report Key11567198
MDR Text Key242170817
Report Number3002808486-2021-01021
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
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2021
Is This An Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2021
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

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