MAUDE Adverse Event Report: COOK, INC.; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Strut fracture (1602)

Patient Problem Foreign body, removal of (2365)

Event Date 01/09/2013

Event Type  Injury  

Event Description

A pt underwent a gunther tulip filter retrieval on (b)(6) 2013 at hospital 2 (hup).The physician indicated the filter had fractured and that the retrieval had failed at hospital 1 because the hook or legs were embedded; but intact.The device was successfully removed intact at hospital 2.Cook rep is trying to get additional info.Info not provided by the reporter.

Manufacturer Narrative

(b)(4).Catalog # is unk; however, could be either k072240 or k043509.Event is still under investigation.

Manufacturer Narrative

Investigation evaluation is based solely on event description, since no device or imaging have been available for examination.It is unk when the gunther tulip filter was implanted and also the pt's medical history.During the course of investigation, a review of the instructions for use (ifu), manufacturing instructions (m), quality control (qc), specifications, and trends was conducted.No evidence to suggest device failure based on information provided.It is cook's experience that fracture is secondary to perforation of ivc.Filter perforation of the vena cava wall is a well known risk.Several case reports in the published medical and scientific literature, describe filter perforation of the vena cava wall.Changes to the filter configuration and to the filter placement, is known to cause stress and possibly fracture to the filter wires due to e.G.Respiratory movements.Also scientific literature describes that manipulation in the area of filter placement could also contribute to change in filter configuration.Fracture of the wire is an uncommon, but known risk in relation to filter implant.A reference is made to the instructions for use: in potential adverse events are mentioned- damage to the vena cava, pulmonary embolism, filter embolization, vena cava perforation, vena cava occlusion or thrombosis, hemorrhage, hematoma at vascular access site, infection at vascular access site, death.Based on the limited information provided, the exact root cause for what caused the filter fracture and difficult retrieval cannot be determined.We will continue to monitor the device.Per the quality engineering risk assessment (qera), no further action is required.

Event Description

It is unk if the pt underwent any additional procedures or any adverse effects at this time.Information has been requested but none have been provided by the reporter.

• Brand Name: UNK
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4054079
• MDR Text Key: 4730760
• Report Number: 1820334-2014-00398
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2013
• Event Location: Hospital
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other