MAUDE Adverse Event Report: COOK, INC.; NONE

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

A pt underwent a aaa graft implant.During the procedure, the sheath was embolizing hydrophilic material.The physician performed a biopsy confirming the embolization of hydrophilic matter.The pt's current condition is unk as it was not provided by the reporter.

Manufacturer Narrative

(b)(4).Event evaluation: still under investigation.

Manufacturer Narrative

During investigation , a review of complaint history, instructions for use (ifu) and trends was conducted.The zenith aaa endovascular device has completed design control requirements showing the device meets the predetermined requirements and that the requirements meet the needs of the user.Zenith products are shipped with an ifu listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.The event shall be trended as resulting in moderate harm to the patient, as biopsies were performed.Minimal information was provided to assist with this case and based on the available information a definitive root cause can not be determined or reported at this time.The appropriate internal personnel have been notified and will continue to monitor for similar complaints.

Event Description

Biopsies confirmed embolization of hydrophilic matter.

• Brand Name: UNK
• Type of Device: NONE
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4218540
• MDR Text Key: 22159325
• Report Number: 1820334-2014-00547
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• 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
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 10/07/2014
• 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