MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Hospital reported that the stent came off the balloon.No other devices in place.

Manufacturer Narrative

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: theresa morin, manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3779142
• MDR Text Key: 18296845
• Report Number: 1219977-2014-00131
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/21/2014
• 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
• Treatment: 7FR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR