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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # igtcfs-65-2-uni-celect-pt.Similar to device under 510(k) k121629.Summary of investigational findings: an investigation of the returned femoral introducer and blue sheath confirmed the reported difficulties in advancing the femoral cup through the sheath tip and the reported horizontal secondary leg is probably a consequence of attempts to advance and/or retract the pre-expanded filter.No evidence to suggest product was not manufactured to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: venogram was done from (r) iliac vein to position filter correctly.Filter was advanced through 7f sheath from set, but could not advance further because of something/obstruction in sheath.Filter was already partly out of sheath and could not be taken out/removed.Struggle to deploy because of obstruction in sheath.Filter was placed and patient was stable.One of the short legs is horizontal in ivc.Rest of filter is correctly in ivc.Going to cause difficulty for retrieval.Patient outcome: filter was placed and patient was stable.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.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK 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 Key: 6265749
• MDR Text Key: 65350386
• Report Number: 3002808486-2017-00033
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)180717(10)E3349592
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57