MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Emboli is included as a possible complication in the instructions for use (ifu) for the indigo lightning system.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2022, the patient underwent a medical procedure in the left pulmonary artery using an indigo system aspiration catheter 12 (cat12).On (b)(6) 2022, two days post procedure, a ct scan showed a new pulmonary embolus.The patient was treated with medication.It is unknown if the secondary emboli is an additional thromboembolic event or due to thrombus migration during the procedure.Left pulmonary embolus was reported to be an adverse event with a possible relationship to the indigo aspiration system and index procedure.The event is considered ongoing.
Event or Problem Description
On (b)(6) 2022, the patient underwent a medical procedure in the left pulmonary artery using an indigo system aspiration catheter 12 (cat12).On (b)(6) 2022, two days post prodecure, a ct scan showed a new pulmonary embolus.The patient was treated with medication (heparin and eliquis).It is unknown if the secondary emboli is an additional thromboembolic event or due to thrombus migration during the procedure.Left pulmonary embolus was reported to be an adverse event with a possible relationship to the indigo aspiration system and index procedure.The event was considered resolved as of 12 jan 2023.
Additional Manufacturer Narrative
Please note that the following section was updated based on the additional information received from the clinical team on 12march2025: 1.Section b.Box 5.Describe event or problem.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15874252
• Report Number: 3005168196-2022-00558
• Device Sequence Number: 11379801
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 815948022577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2025
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H00000487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005