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

Model Number 85445

Device Problems Break (1069); Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

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

Event Date 11/12/2019

Event Type  malfunction  

Event Description

An atrium 7 x 22 x 80 covered icast stent was implanted into the right renal artery and inflated via insufflator.The balloon burst and the tip with balloon piece broke off of the catheter.The catheter was pulled back and the balloon piece was retrieved via snare, brought into a sheath, and removed from the patient.

• Brand Name: ICAST
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental boulevard; merrimack NH 03054
• MDR Report Key: 9362178
• MDR Text Key: 167594589
• Report Number: 9362178
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85445
• Device Catalogue Number: 85445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA