MAUDE Adverse Event Report: COOK, INC.

Device Problem Strut fracture (1602)

Patient Problem Foreign body, removal of (2365)

Event Date 07/10/2013

Event Type  Injury  

Event Description

A pt underwent a gunther tulip filter retrieval on (b)(6) 2013 at hospital 2.The physician indicated that the filter had fractured and that the retrieval was unsuccessful at hospital 1 because the hook or legs were embedded.However, the filter was successfully removed at hospital 2.At this time, no add'l info has been provided, but 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

No product or imaging was provided for evaluation however, during investigation, a review of the instructions for use (ifu), manufacturing instructions (mi), quality control (qc), specifications, trends was conducted.No lot number was provided nor information regarding implant date however, it is known 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 information provided and the investigation results, we are unable to determine with certainty the root cause for the difficulty experienced.We will continue to monitor this device.Per quality engineering risk assessment (qera), no further action is required.

Event Description

No additional information was provided regarding patient outcome.

• Brand Name: UNK
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; p.o. box 489; bloomington, IN 47404 ; 8122392235
• MDR Report Key: 4036825
• MDR Text Key: 4849284
• Report Number: 1820334-2014-00401
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/10/2013
• 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