MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85444
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The stent came off of balloon after inserted into pt.Stent and balloon were retrieved and returned to sterile field.

• Brand Name: ICAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth dr; hudson NH 03051
• MDR Report Key: 6935532
• Report Number: 6935532
• Device Sequence Number: 461306
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: (01)00650862854442(17)200322
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2017
• Report Date (Section F): 09/07/2017

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
• Operator of Device: Physician
• Device Expiration Date: 03/22/2020
• Device Model Number: 85444
• Device Catalogue Number: 85444
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 79
• Date Report Sent to FDA: 09/07/2017