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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52916
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation is still in progress.
 
Event Description
Description of event according to initial reporter: "left ij access was used to place filter.The deployment sheath took the anatomy turn but the filter could not take the turn and went out the side of the sheath." information received 01dec2017: filter was never deployed so the deployment part with filter attached was removed from the sheath.A new deployment sheath was used on each attempt.Three attempts with three devices in total ((b)(4)).They were not able to put a filter in the patient that day.Patient was brought back the following day and used a more supportive long sheath and a filter from another company.After dr.Is attributing it to patient anatomy.He wants a more supportive deployment sheath.Patient outcome: no adverse effects reported on the patient due to this occurrence.
 
Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: investigation is based on event description and returned device.(b)(4) are related.Two jugular introducers, two blue sheaths, and one long dilator were returned in one plastic bag.Consequently, it is unknown, which device relates to which complaint: sheath 1 is severely penetrated approx.24cm from distal tip.The filter is in proper shape and still attached to the introducer.The protection sheath is kinked where the filter hook is attached to the grasping hook.Sheath 2 is severely penetrated approx.33cm from distal tip.The protection sheath is kinked where the filter hook is attached to the grasping hook.The filter is in proper shape, but released, probably because of the kink.Based on these findings the difficulties encountered are probably related to the patient anatomy as reported.Therefore, rep.Follow-up may be relevant to discuss "more supportive deployment sheath".No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that tit did not perform as intended.Cook medical will continue to monitor for similar events.
 
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Brand Name
GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA  4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7120307
MDR Text Key95769670
Report Number3002808486-2017-02472
Device Sequence Number1
Product Code DTK
UDI-Device Identifier10827002529165
UDI-Public(01)10827002529165(17)200519(10)E3586981
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/18/2018
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 Model NumberG52916
Device Catalogue NumberIGTCFS-65-1-JUG-TULIP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Distributor Facility Aware Date12/01/2017
Device Age6 MO
Initial Date Manufacturer Received 11/30/2017
Initial Date FDA Received12/15/2017
Supplement Dates Manufacturer Received01/02/2018
Supplement Dates FDA Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age83 YR
Patient Weight132
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