MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ASPIRA; ASPIRA PLEURAL DRAINAGE SYSTEM

Catalog Number	4992301/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.No lot number was provided; thus, the device history record could not be reviewed and a search of the complaint database could not be performed.
Event or Problem Description
Medwatch report was received from the fda stating: with surgeon's insertion of an aspira catheter, the complexity of the system caused a retained stylet.Patient with lung cancer and malignant effusions requiring a chest catheter.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
The account alleges that due to the complexity of the aspira catheter system, insertion of the device caused a retained stylet.The patient did not sustain any injuries due to the retained stylet.The stylet was removed from the patient.

• Brand Name: ASPIRA
• Common Device Name: ASPIRA PLEURAL DRAINAGE SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23620060
• Report Number: 1721504-2025-00654
• Device Sequence Number: 9962292
• Product Code: DWM
• UDI-Device Identifier: 00884450394861
• UDI-Public: 00884450394861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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
• Device Catalogue Number: 4992301/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown