MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	THNDRRED62SKIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	10/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 , the patient underwent a thrombectomy procedure in the right m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a neuron max 6f 088 long sheath (neuron max) and a velocity delivery microcatheter (velocity).During the procedure, one pass was completed with modified thrombolysis in cerebral infarction (mtici3).Post procedure, on (b)(6) 2022 , mri of the brain showed evidence of infarcts throughout the right mca distribution involving mostly the right frontal lobe and right basal ganglia movement as well.There were also infarcts present in the right mca distribution.On (b)(6) 2022 , the patient was discharged to skilled nursing facility.Medication eliquis 5 mg twice daily was started from (b)(6) 2022 and the patient was continued on aspirin daily.It was reported that the event was unresolved at time of study exit or death due to a different event.On (b)(6) 2023, it was reported that the cec chair adjudicated infarcts post procedure to be an adverse event with a possible relationship to the index procedure, a possible relationship to the index stroke and a possible relationship to the penumbra system.
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Emboli is included as a possible complication in the instructions for use (ifu) for the penumbra system.

• Brand Name: PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER
• 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: 16661137
• Report Number: 3005168196-2023-00150
• Device Sequence Number: 6615794
• Product Code: NRY
• UDI-Device Identifier: 00815948024359
• UDI-Public: 815948024359
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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
• Report Date (Section B): 04/02/2023
• 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: 05/25/2025
• Device Catalogue Number: THNDRRED62SKIT
• Device Lot Number: F00000997
• 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: 03/08/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005