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

Catalog Number IGTCFS-65-1-UNI-CELECT-PT

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: igtcfs-65-1-uni-celect-pt.Summary of investigational findings: investigation is based on event description and returned product.The jugular filter introducer, with filter resheated, is returned.The red safety button is not pressed, i.E.System is still locked.The filter can easily be deployed and generally looks very fine.Leg distances within specifications.It sounds like the filter was never released during the procedure, as it would likely have been mentioned if recapture was performed.This is supported by the finding that the safety button is not pressed.This then indicates that the "catching on something" felt by the user actually is the locked introducer making deployment impossible.From the ifu: when the filter position is correct, push the red safety button to prepare filter release.There is found no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: a patient of unknown age and gender underwent an insertion of a vena cava filter via jugular approach.While attempting to deploy the filter was deploying at an angle and was not smooth.The physician stated it felt as though it catching on something.The device was resheathed and attempted to be deployed again.It was stated that the same occurred again so the physician resheathed the device and removed.The procedure was completed with another of the same filter.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.

• 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: 5899286
• MDR Text Key: 52845452
• Report Number: 3002808486-2016-00957
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)181111(10)E3385620
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2015
• 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