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

Model Number 85441

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Event Description

The stent on the icast fell off or slipped off the balloon after the device was opened onto the sterile field.This occured prior to trying to implant the device in the patient.

• Brand Name: ICAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth dr; hudson NH 03051
• MDR Report Key: 6803805
• MDR Text Key: 83025576
• Report Number: 6803805
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2017,07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/05/2019
• Device Model Number: 85441
• Device Catalogue Number: 85441
• Other Device ID Number: DIMENSIONS 5MMX22MMX80CM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 97