• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 07/12/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4) pt identifier) unknown as information was not provided. Age/date of birth) unknown as information was not provided. Sex) unknown as information was not provided. Weight) unknown as information was not provided. Model/lot #) igtcfs-65-1-jug-celect-pt. (b)(4). Investigation is still in progress.

 
Event Description

Description of event according to complainant: "the hub of the filter deployment set was leaking blood but the physician was able to use it to complete the procedure. " update: it was the hub of the white dilator that was leaking blood. When they try to remove the luer lock from the power inject, they could not get it off. The luer lock that is part of the hub was spinning freely. The seams on that part of the dilator seemed to crack open. 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

(b)(4). Model #/lot #) igtcfs-65-1-jug-celect-pt. (b)(4). Summary of investigational findings: approx. 8 cm of the proximal end of the dilator is returned. The luer inside the dilator hub had loosened, but the shells are still locked, ie the luer slipped the shells when removed from the power injection. After opening the shells, the glue appeared placed at a very small part of the thread only. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: "the hub of the filter deployment set was leaking blood but the physician was able to use it to complete the procedure. " update: it was the hub of the white dilator that was leaking blood. When they try to remove the luer lock from the power inject, they could not get it off. The luer lock that is part of the hub was spinning freely. The seams on that part of the dilator seemed to crack open. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5828936
MDR Text Key50633500
Report Number3002808486-2016-00750
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2016
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? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/28/2016 Patient Sequence Number: 1
-
-