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

Model Number	85416
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
We have received your reported medwatch (b)(4) from the fda.Post inflation of icast (balloon expandable stent), the balloon broke off the catheter.This was left into the patient¿s fistula.Interventional radiology (ir) doctor took approximately 30 minutes to remove the balloon.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: d9, h6 ¿received an fda medwatch (0500360000-2024-8006) which stated the following: post inflation of icast (balloon expandable stent), the balloon broke off the catheter.This was left into the patient¿s fistula.Interventional radiology (ir) doctor took approximately 30 minutes to remove the balloon.¿ the device in question was unable to be provided for the investigation and no images were provided of the device.There were also no answers provided for the multiple attempts to obtain more information regarding this case.As such the complaint cannot be confirmed.A contemporaneous sample was not requested as the conditions that the device in question experienced during the procedure are unknown.The investigation cannot conclude that the separation of the balloon was due to the manufacture of the device.It is likely that the balloon was not allowed sufficient time to deflate prior to attempting to withdraw the catheter back through the introducer sheath.Additionally, fluoroscopic guidance may not have been used to ensure the balloon was fully deflated prior to withdrawal back through the sheath.Without more detail or the device in question the root cause of the separation is impossible to define.It is important to note that the product in question had expired on april 09, 2024.The exact date of the event was not provided but the user stated it was in the month of april 2024.The date the manufacturer was notified was 6 months later in dec 2024.Based on this review of the device history records there were no deviations or non-conformances noted and there have been no significant design, material, procedural or process changes around the time of device manufacture have been identified.There have been no other complaints identified for this lot of catheters (470957).The component separation has not been confirmed as the product was not returned and no images provided.There were also no answers to the multiple questions asked about the incident from the complainant.There is no deficiency identified in the design labeling, and risk documentation nor has a manufacturing problem been identified.There were also no trending or occurrence excursions identified.The root cause associated with this complaint is impossible to define due to the lack of details and physical product used in the case.

• Brand Name: ICAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 21023688
• Report Number: 3011175548-2024-000025
• Device Sequence Number: 8310832
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: (01)00650862854169(17)240409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Device Lot Number: 470957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown