MAUDE Adverse Event Report: PENUMBRA, INC. LIGHTNING ASPIRATION TUBING; QEW

Catalog Number	LITNG12HTORQ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in the segmental and subsegmental branches of the pulmonary arteries using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), an indigo system separator 12 (sep12), and a penumbra engine (engine).There were no reported procedural complications, and the access site did not show signs of bleeding.Forty-three minutes post-procedure the patient developed anemia, with a drop in hemoglobin of 2 g/dl from baseline.The patient was administrated one unit of packed red blood cells (prbcs).On (b)(6) 2024, the patient was administered an additional one unit of prbcs with no complications related to the transfusion.It was reported that the dressing remained dry and clean, and the patient was fasting for a chest computed tomography (ct) scan scheduled for the next day.On (b)(6) 2024, the patient was administered two more units of prbcs without any adverse body reaction.On (b)(6) 2024, the patient reported improved wellbeing, mobility and decrease in inflammatory parameters.The patient was considered independent and required minimal nursing care.The event is considered resolved.The independent medical reviewer (imr) adjudicated the anemia as a serious adverse event with a possible relationship to the lightning and a probable relationship to the index procedure.
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report: 3005168196-2025-00018.Section g.Box 2.Report source.

• Brand Name: LIGHTNING ASPIRATION TUBING
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21174272
• Report Number: 3005168196-2025-00018
• Device Sequence Number: 4538758
• Product Code: QEW
• UDI-Device Identifier: 00815948022904
• UDI-Public: 00815948022904
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2025

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 Catalogue Number: LITNG12HTORQ100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 71 YR
• Patient Sex: Female