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

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.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.
Event or Problem Description
On (b)(6) 2024, the patient developed anemia following neck of femur surgery, with hemoglobin levels measuring 7.7 g/dl.On (b)(6) 2024, the patient underwent a thrombectomy procedure in the right upper lobe, right interlobar segment, right middle lobe, left upper lobe, and lingula using a lightning aspiration tubing (lightning) via right femoral vein access.It was reported that the mobile thrombus in the right atrium observed on the pre-procedural computed tomography angiography (cta) taken on (b)(6) 2024, was not removed.It was reported that the patient was administered anticoagulants prior to the thrombectomy which may have been the reason that the thrombus was not seen via imaging at the time.However, control imaging confirmed complete recanalization of the lung vessels.Estimated blood loss was 500 ml, and no procedural complications were reported.The patient was then transferred to the intensive care unit (icu).The patient's hemoglobin then dropped to 6.8 g/dl, and a transfusion of one unit of red blood cells was administered.On (b)(6) 2024, the patient's hemoglobin level was rechecked and found to be 7.1 g/dl.One additional unit of red blood cells was administered to raise the hemoglobin level.The transfusion intervention target was set at 7.5 g/dl or below.The patient's hemoglobin remained stable, not falling below 7.5 g/dl until discharge, and no further intervention was required.The patient will follow up with cardiology in three months for a repeat echocardiogram.The event is considered resolved.The independent medical reviewer (imr) adjudicated the low hemoglobin as a serious adverse event with a possible relationship to the lightning, and a possible relationship to the index procedure.
Event or Problem Description
On (b)(6) 2024, the patient developed anemia following neck of femur surgery, with hemoglobin levels measuring 7.7 g/dl.On (b)(6) 2024, the patient underwent a thrombectomy procedure in the right upper lobe, right interlobar segment, right middle lobe, left upper lobe, and lingula using a lightning aspiration tubing (lightning) via right femoral vein access.The control imaging confirmed complete recanalization of the lung vessels.It was reported that there was an estimated blood loss of 500 ml, and no procedural complications were reported.The patient was then transferred to the intensive care unit (icu).The patient's hemoglobin then dropped to 6.8 g/dl, and a transfusion of one unit of red blood cells was administered.On (b)(6) 2024, the patient's hemoglobin level was rechecked and found to be 7.1 g/dl.One additional unit of red blood cells was administered to raise the hemoglobin level.The transfusion intervention target was set at 7.5 g/dl or below.The patient's hemoglobin remained stable, not falling below 7.5 g/dl until discharge, and no further intervention was required.The patient will follow up with cardiology in three months for a repeat echocardiogram.The event is considered resolved.The independent medical reviewer (imr) adjudicated the low hemoglobin as a serious adverse event with a possible relationship to the lightning, and a possible relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 1 mfr report: 3005168196-2024-00361.1.Section b.Box 5.Describe event or problem.

• Brand Name: LIGHTNING ASPIRATION TUBING
• 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: 20547370
• Report Number: 3005168196-2024-00361
• Device Sequence Number: 18111188
• Product Code: QEW
• UDI-Device Identifier: 00815948022928
• UDI-Public: 00815948022928
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024
• 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 Catalogue Number: LITNG12HTORQ115
• 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: 09/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005