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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-JUG-CELECT-PT
Device Problems Filter (816); Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2015
Event Type  No Answer Provided  
Manufacturer Narrative

(b)(4). Catalog # igtcfs-65-1-jug-celect-pt. Investigation is still in progress.

 
Event Description

Description according to complainant: during an ivc filter placement with jugular approach procedure, the primary legs on the ivc filter would not open. The physician released the filter instead of re-sheathing it and getting a new one. A gunther tulip retrieval set was used to retrieve the defective filter then placed a new jug celect platinum with no issues. Patient outcome: the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Catalog # igtcfs-65-1-jug-celect-pt. Summary of investigational findings: retrieval system was returned with the filter attached. No error was found on the filter. No imaging was provided and the root cause cannot be determined based on the available information and the returned product. However, the filter legs may have been somehow obstructed from fully expanding due to e. G. Ivc anatomical conditions, clots or if not placed in ivc. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred. (b)(4). Catalog # igtcfs-65-1-jug-celect-pt. Summary of investigational findings: retrieval system was returned with the filter attached. No error was found on the filter. No imaging was provided and the root cause cannot be determined based on the available information and the returned product. However, the filter legs may have been somehow obstructed from fully expanding due to e. G. Ivc anatomical conditions, clots or if not placed in ivc. No evidence to suggest that this device was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description according to complainant: during an ivc filter placement with jugular approach procedure, the primary legs on the ivc filter would not open. The physician released the filter instead of re-sheathing it and getting a new one. A gunther tulip retrieval set was used to retrieve the defective filter then placed a new jug celect platinum with no issues. Patient outcome: the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
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 Key5185279
MDR Text Key30260207
Report Number3002808486-2015-00138
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/19/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/28/2015
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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