MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST

Model Number 85412

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fever (1858)

Event Date 02/17/2014

Event Type  Injury  

Event Description

A stent was placed in patient's right renal artery for fibromuscular dysplasia (fmd) without complication.Physician stated patient had low grade fever, and non specific abdominal pain the day following case.White blood cell count did not go up, and patient was stable and discharged from the hospital.

Manufacturer Narrative

We are in the process of performing the investigation.A follow-up report shall be submitted upon completion of the device evaluation.

• Brand Name: ICAST
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3693133
• MDR Text Key: 4256528
• Report Number: 1219977-2014-00107
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 85412
• Device Catalogue Number: 85412
• Device Lot Number: 10817970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 69