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

Model Number	C1002
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: [lap cholecystectomy] event description: hospital: [hospital name] the event date is unknown.Due to these issues, (name redacted) has switched to the urotech urology catheter of 5 fr (1.67mm), 70 cm length.He noted the urotech catheter is cheaper and more convenient for him.He introduces it via a reusable introducer from a different brand and secures it with a cholangiogram clip.He expressed that he will no longer be using our catheter.Despite his concerns, (name redacted) was satisfied with our visit and allowed us to attend a surgery to observe our catheter in use.During the laparoscopic cholecystectomy, we witnessed the difficulties firsthand.The patient had a thin and small cystic duct, and the c1002 catheter experienced resistance, preventing insertion and necessitating additional force, which could potentially damage the cystic duct or even perforate it (what has happened to him before).(name redacted) continued the procedure with the urotech catheter, which he was able to insert due to its smaller diameter (1.67mm).Our catheter¿s diameter ranges from 2-6.7mm.It is also worth mentioning that (name redacted) , another surgeon at the same hospital, has been using our aerostat catheter for almost 10 years without any issues and is very satisfied with its performance.¿ type of intervention: [unknown] patient status: [patient recovered without further complications post-surgery.].
Additional Manufacturer Narrative
The event unit is not anticipated to be return to applied medical for evaluation and the lot number has not been provided.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: [lap cholecystectomy].Event description: hospital: [hospital name].The event date is unknown.Due to these issues, (name redacted) has switched to [competitor device] of 5 fr (1.67mm), 70 cm length.He noted the [competitor device] is cheaper and more convenient for him.He introduces it via a reusable introducer from a different brand and secures it with a cholangiogram clip.He expressed that he will no longer be using our catheter.Despite his concerns, (name redacted) was satisfied with our visit and allowed us to attend a surgery to observe our catheter in use.During the laparoscopic cholecystectomy, we witnessed the difficulties firsthand.The patient had a thin and small cystic duct, and the c1002 catheter experienced resistance, preventing insertion and necessitating additional force, which could potentially damage the cystic duct or even perforate it (what has happened to him before).(name redacted) continued the procedure with the [competitor device], which he was able to insert due to its smaller diameter (1.67mm).Our catheter¿s diameter ranges from 2-6.7mm.It is also worth mentioning that (name redacted) , another surgeon at the same hospital, has been using our aerostat catheter for almost 10 years without any issues and is very satisfied with its performance.¿ type of intervention: [unknown].Patient status: [patient recovered without further complications post-surgery].
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-conformance's 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 has performed a historical trend analysis and review of production records and no trends were identified.This event was initially reported based on the description of the event.However, based on further examination of the event description and the risk documentation, applied medical determined that this event is not reportable as it is unlikely to lead to death or serious deterioration in the state of health.

• 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: 20605577
• Report Number: 2027111-2024-00894
• Device Sequence Number: 7929027
• Product Code: FGE
• UDI-Device Identifier: 00607915116682
• UDI-Public: (01)00607915116682
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C1002
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown