MAUDE Adverse Event Report: ATRIUM ICAST COVERED STENT

Catalog Number 85420

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 08/31/2016

Event Type  malfunction  

Event Description

Atrium balloon stent - upon removal of balloon portion, the balloon snapped off within the introducer, physician able to retrieve balloon.

• Brand Name: ICAST COVERED STENT
• Type of Device: ICAST COVERED STENT
• Manufacturer (Section D): ATRIUM; hudson NH 03051
• MDR Report Key: 5938997
• MDR Text Key: 54508661
• Report Number: MW5064624
• Device Sequence Number: 1
• Product Code: JCT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 85420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 119