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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-2-UNI-CELECT
Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Catalog #: igtcfs-65-2-uni-celect. Similar to device under 510(k) k090140. (b)(4). Summary of investigational findings: evaluation is based on the description and the available images; the exact reason for the difficulties encountered cannot be determined, but based on information provided the filter legs most likely twisted during the reloading procedure. Or, if not during reloading, the legs may have twisted during the procedure, when advancing the filter through the sheath. There is no evidence to suggest that the device was not manufactured according to specification. Cook medical will continue to monitor for similar events.
 
Event Description
Description of event according to complainant: as per problem statement: "the dr. Usually uses the jugular access kit but the nurse opened the uniset by accident. So he had to transfer the filter from the femoral sheath to the jugular sheath. He thinks this is where the legs may have been stuck together. He placed the filter through the jugular access. After the cavagram, he observed the legs did not fully deploy at infrarenal site. He performed a ct on (b)(6) 2014 and this showed that the legs had deployed and the filter had migrated a little. He was not concerned about the issues that occurred. Filter will be left in permanently. " patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameCOOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5895692
MDR Text Key52727316
Report Number3002808486-2016-00869
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeIR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/13/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIGTCFS-65-2-UNI-CELECT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2014
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/01/2013
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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