MAUDE Adverse Event Report: COOK, INC.

Device Problem Strut fracture (1602)

Patient Problem Foreign body, removal of (2365)

Event Date 03/20/2013

Event Type  Injury  

Event Description

A pt underwent gunther tulip filter retrieval on (b)(6) 2013 at hospital 2.The physician indicated that the filter had fractured and that the retrieval failed at hospital 1 due to hook or legs embedded and an extravascular piece in the vertebral body, but was successfully removed at hospital 2.The cook rep is attempting to gather add'l info.

Manufacturer Narrative

(b)(4).Although catalog number is unk, but could be either k072240 or k043509.Event eval: still under investigation.

Manufacturer Narrative

Catalog # is unknown but the 510(k) # could be either k072240 or k043509.Investigation evaluation is based solely on event description, since no device or imaging was provided for examination.During investigations, a review of the instructions for use (ifu), manufacturing instructions (mi), quality control (qc), specifications, and trends was conducted.Per the event description.A patient underwent gunther tulip filter retrieval on (b)(6) 2013 at hospital 2 ((b)(6)).The physician indicated that the filter had fractured and that the retrieval failed at hospital 1 due to hook or legs embedded and an extravascular piece in the vertebral body, but was successfully removed at hospital 2.It is unknown when the filter was implanted and if patient underwent any surgery during filter implant.There is no evidence to suggest that this device was not manufactured according to specifications.It is cooks' 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 (ifu).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 above, the exact root cause for the reported difficulty can not be determined with certainty.The appropriate internal personnel have been notified and we will continue to monitor this device.No further action will be taken.

Event Description

No information has been provided regarding patient outcome.

• Brand Name: UNK
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4036822
• MDR Text Key: 4883819
• Report Number: 1820334-2014-00400
• 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: 08/20/2014
• 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: 03/20/2013
• Device Age: NA
• 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