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

Model Number	LITNGBT7TQ130-A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Penumbra lighting catheter broke off inside of patient's left arm during an arteriovenous (av) fistula thrombectomy.

• 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: 20831478
• Report Number: 20831478
• Device Sequence Number: 12067811
• Product Code: QEW
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024
• Report Date (Section F): 09/17/2024

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
• Device Model Number: LITNGBT7TQ130-A
• Device Catalogue Number: LITNGBT7TQ130-A
• Device Lot Number: H00004316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/17/2024