MAUDE Adverse Event Report: Q'APEL MEDICAL LLC ARMADILLO; CATHETER, PERCUTANEOUS

Model Number	FG 00464-07
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The armadillo device was put into support mode (saline was removed).Blood was visualized in the balloon hub of the device indicating the balloon likely ruptured.The device was removed and exchanged for a new armadillo catheter.

• Brand Name: ARMADILLO
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): Q'APEL MEDICAL LLC; 4245 technology drive; fremont CA 94538
• MDR Report Key: 24332021
• Report Number: 24332021
• Device Sequence Number: 14671660
• Product Code: DQY
• UDI-Device Identifier: 00857545008066
• UDI-Public: (01)00857545008066
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/06/2026
• Report Date (Section F): 02/06/2026

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 Model Number: FG 00464-07
• Device Catalogue Number: SF7072-95-27-30
• Device Lot Number: FG250723K-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/06/2026