MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	LITNGFHT100H1-D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While priming the thrombectomy device on the table we noticed the devices electronics was defective.We tried a few times with the support of the rep form penumbra to trouble shoot the error but no luck.Item was never used on patients.Item removed from field and new product opened on field that work without issue.

• Brand Name: INDIGO SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 24626093
• Report Number: 24626093
• Device Sequence Number: 15666638
• Product Code: QEW
• UDI-Device Identifier: 00815948029880
• UDI-Public: (01)00815948029880
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2026
• Report Date (Section F): 03/13/2026

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: LITNGFHT100H1-D
• Device Catalogue Number: LITNGFHT100H1
• Device Lot Number: F00016453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• 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: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/13/2026