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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
Model Number G34309
Device Problem Bent (1059)
Patient Problems Discomfort (2330); Valvular Stenosis (2697)
Event Date 12/18/2017
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Description of event according to initial reporter: "an (b)(6) female had a cook celect platinum navalign jugular vena cava filter set, g34309, prophylactically implanted on (b)(6) 2017. Patient underwent a filter retrieval procedure on (b)(6) 2017. For the removal procedure, the gunther tulip vena cava filter retrieval set was used (g13287, lot# 8258931). The retrieval set was inserted and hooked on the filter per usual. While attempting to over sheath the filter with the coaxial sheath set, the filter hook bent over the snare ((b)(4)) and the 11fr sheath separated from its hub ((b)(4)), simultaneously. At this point, the physician was going to un-snare the filter and remove all parts of the kit and start with a new retrieval set but as the filter hook was bent over the snare, the snare could not be removed. The physician had to completely dismantle the set in order to remove all parts of the gtrs leaving only the snare in the patient. Another retrieval set (g13287, lot# unknown) was pulled. The device was opened, flushed and when the physician pulled on the hub, the sheath became detached just as it did with the first kit ((b)(4)) and therefore could not be used to continue the procedure. Since the only large cook sheaths available at the hospital were too short, a device from another manufacturer was opened and used to continue and complete the procedure. The sheath was able to collapse the filter without incident and was therefore removed from the patient. All primary and secondary struts of the filter were still attached. Other than some discomfort and just slightly above normal blood loss (from changing out so many devices due to difficulties), no concern to the physician and no transfusion. It was noted the tips of both sheaths of the first gtrs (lot# 8258931) were damaged; jagged, bent, cut. There was nothing left inside of the patient, no filter or sheath fracture, no significant changes, no patient harm, and a normal post-venogram was seen. 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® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
Type of DeviceDTK 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 Key7166943
MDR Text Key97501984
Report Number3002808486-2018-00038
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34309
Device Catalogue NumberIGTCFS-65-1-JUG-CELECT-PT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date12/18/2017
Device Age18 mo
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/14/2016
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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