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

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

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: igtcfs-65-2-jug-celect-pt.Similar to device under 510(k) k121629.(b)(4).Summary of investigational findings: no product returned for investigation and without the actual complaint device the exact reason for the difficulties encountered when attempting to release the filter cannot be determined.However, based on information provided "when the delivery system was removed the device was still attached", it is assumed the blue introducer sheath was not withdrawn and the filter was not expanded, when attempts were made to release the filter, ie the filter was still inside the sheath.Ifu: stabilize the introducer, and withdraw the introducer sheath and protection sheath until the protection sheath and handle are connected.At this point the filter is expanded, still connected to the filter introducer.Verify that the sheath hub and handle are connected to ensure that the metal mounting point is completely free of the sheath before filter release.When the filter position is correct, push the red safety button to prepare filter release.Investigation found no evidence to suggest the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the device needed to be implanted into the patient.Checked outside the patient, then using the usual technique the device was inserted and was thought to be deployed, however when the delivery system was removed the device was still attached.Checked the device again outside the patient and it deployed properly.Reinserted it and eventually deployed the device but not without difficulty.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 JUGULAR 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: 5895724
• MDR Text Key: 52729444
• Report Number: 3002808486-2016-00872
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002343105
• UDI-Public: (01)10827002343105(17)171117(10)E3276333
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-2-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Date Device Manufactured: 11/17/2014
• 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