MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA ENGINE; NRY

Model Number	PMXENGN
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the bilateral femoral and iliac arteries and inferior vena cava using a penumbra engine (engine), lightning aspiration tubing (lightning), and a guidewire.During the procedure, the physician aspirated some clot in the target vessel using the engine and lightning.Subsequently, the physician turned off the engine to use balloon maceration.Upon turning the engine back on, the indicator light on the lightning unit failed to illuminate.To troubleshoot, the lightning was unplugged from the engine and re-plugged, and the engine was unplugged from the power outlet and re-plugged; however, the issue was not resolved.It was reported that a new lightning was plugged into the engine, and it also failed to illuminate.Therefore, the engine was not used for the remainder of the procedure.The procedure was completed using a new engine and the same lightning.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned engine could not confirm the reported complaint.Evaluation revealed that the device was undamaged and functional.During the functional test, the engine was tested with a demonstration canister, and vacuum was achieved within specification.The engine was tested with a demonstration lightning unit and functioned as indented.The green light illuminated on the demonstration lightning unit.Penumbra engines are inspected at incoming quality control which includes a visual inspection as well as a verification of test results to ensure specifications for each output are met.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text: placeholder.

• Brand Name: PENUMBRA ENGINE
• Common Device Name: NRY
• 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: 12840808
• Report Number: 3005168196-2021-02621
• Device Sequence Number: 17222767
• Product Code: NRY
• UDI-Device Identifier: 00815948020030
• UDI-Public: 00815948020030
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PMXENGN
• Device Catalogue Number: PMXENGN
• Device Lot Number: S10418-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005