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

Model Number	LITNGFHT115BER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The computer attachment piece of the penumbra lightning flash (16fr) aspiration catheter was not working.When attached to the canister and plugged in, it would light up green for a second and then would shut off and there was no color at all.Also, no suction was available when turned on.We undid everything and tried to reattach it again a few more times and it would never stay lit up green.This has happened recently before and we were told to open up a new catheter, so that's what we did and the new one worked fine.

• 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: 20597900
• Report Number: 20597900
• Device Sequence Number: 16682385
• Product Code: QEW
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 08/08/2024
• Report Date (Section F): 08/08/2024

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: LITNGFHT115BER
• Device Lot Number: C00015135
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2024
• 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
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 08/08/2024