MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES AEROSTAT®; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C1002
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: percutaneous cholangiography catheter wi.Event description: during the deployment of the retention cone in the cystic duct, a break in continuity of the posterior wall of the cystic duct is evident, caused by the retention cone.Wide dissection of the cystic duct was required until its insertion into the biliary tract.Cholangiography could not be performed.Additional information provided on 19feb2025: the entire cone was inserted into the duct.Yes, the cone was expanded.Yes, it was fully expanded.No information on the size of the duct.Yes, it was difficult to open/close.Type of intervention: cholangiography could not be performed.Patient status: the procedure could not be completed.
Event or Problem Description
Procedure performed: percutaneous cholangiography catheter wi.Event description: during the deployment of the retention cone in the cystic duct, a break in continuity of the posterior wall of the cystic duct is evident, caused by the retention cone.Wide dissection of the cystic duct was required until its insertion into the biliary tract.Cholangiography could not be performed.Additional information provided on 19feb2025 by email: the entire cone was inserted into the duct.Yes, the cone was expanded.Yes, it was fully expanded.No information on the size of the duct.Yes, it was difficult to open/close.Patient status: the procedure could not be completed.Intervention: cholangiography could not be performed.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: AEROSTAT®
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21599736
• Report Number: 2027111-2025-00410
• Device Sequence Number: 8266466
• Product Code: FGE
• UDI-Device Identifier: 00607915116682
• UDI-Public: (01)00607915116682
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K905738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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 Model Number: C1002
• Device Catalogue Number: 100434901
• Device Lot Number: 1507736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 08/26/2025
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown