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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G34502
Device Problems Mechanical Problem (1384); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Occupation: non-healthcare professional.Name and address for importer site: (b)(4).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "the filter was placed into the sheath, and physician felt resistance as she was advancing the filter thru the sheath.She pulled back and realized the filter was damaged.A new filter was opened and used to complete the procedure." 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.
 
Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Summary of investigational findings: investigation is based on event description and returned device.It was reported that resistance was felt, when advancing the filter through the sheath - the filter was pulled back and was found damaged.Only the femoral introducer with loaded celect-pt filter was returned.No observations to the introducer, but all secondary filter legs were misshapen and not aligned; one was pushed upwards, one was placed on the other side of the primary leg, and others had a too large diameter or were pushed sidewards.It was reported that the filter was pulled back and was found damaged, as if retracted through the check-flo valve and said maneuver probably caused the damages to the filter; according to ifu repositioning of the preexpanded filter is possibly only by advancing the filter, as retracting the filter could damage the secondary filter legs or the caval wall.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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Brand Name
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
MDR Report Key7875902
MDR Text Key120249381
Report Number3002808486-2018-01097
Device Sequence Number1
Product Code DTK
UDI-Device Identifier10827002345024
UDI-Public(01)10827002345024(17)210412(10)E3712145
Combination Product (y/n)N
PMA/PMN Number
K121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/12/2021
Device Model NumberG34502
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT-PT
Device Lot NumberE3712145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Distributor Facility Aware Date08/29/2018
Device Age4 MO
Initial Date Manufacturer Received 08/29/2018
Initial Date FDA Received09/14/2018
Supplement Dates Manufacturer Received10/31/2018
Supplement Dates FDA Received11/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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