MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE

Model Number 85424

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2014

Event Type  Injury  

Event Description

The report states that when the physician was pulling negative pressure to deflate the stent balloon it was noticed that the balloon was dropping very slowly.The physician aspirated with a syringe but still there was fluid remaining in the balloon.He then tried to remove the stent from the pt through the sheath but it would not come back completely into the sheath.The physician removed the whole system, both the delivery catheter and sheath and held manual pressure.It was stated in the room that the balloon might have been inflated with 100% contrast.Pt remained in stable condition.

Manufacturer Narrative

On completion of the eval a follow up report will be submitted.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDIBLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4381073
• MDR Text Key: 5240573
• Report Number: 1219977-2014-00400
• 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
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 10895456
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: GLIDEWIRE 0.35 X 180 CM; BOSTON SCIENTIFIC INTRODUCER SHEATH 7FR X 25 CM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 115