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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 Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Type  Death  
Manufacturer Narrative

Manufacturer ref# (b)(4). Catalog# is unknown but referred to as cook celect platinum filter. Similar to device under. Pma/510(k): k171712. Investigation is still in progress.

 
Event Description

Description of event according to initial reporter: after the neurosurgical procedure and the ¿off-label¿ filter placement in the superior vena cava, the clinical status of the patient (mainly respiratory and cardiac status) worsened progressively, preventing any further interventional procedures. The patient suffered persistent hypoxemia and bradycardia throughout the time in hospital and died 15 days after the filter had been placed. Patient outcome: according to the initial reporter, the patient did experience an 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 DK-46 32
DA DK-4632
Manufacturer Contact
lissi walmann
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key11973112
MDR Text Key255446498
Report Number3002808486-2021-01327
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received06/28/2021
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: 06/10/2021 Patient Sequence Number: 1
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