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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-JUG-CELECT-PERM
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
This additional information received on 08feb2018 as follows: pt allegedly received an implant on (b)(6) 2009 due to pulmonary embolisms. Pt is alleging filter in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.
 
Manufacturer Narrative
Exemption number e2016032e lot. (b)(4). Correction: exemption number and importer name and address. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Manufacturer Narrative
(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog#: unknown but referred to as a cook celect filter. (b)(4). Since catalog# is unknown the 510(k) could be either k061815 or k073374. (b)(4). It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿celect filter implanted". Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "patient received a cook celect filter on (b)(6) 2009". It is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameCOOK CELECT JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key7120338
MDR Text Key266709242
Report Number3002808486-2017-02460
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K073374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-JUG-CELECT-PERM
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date11/30/2017
Event Location No Information
Date Manufacturer Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2017 Patient Sequence Number: 1
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