MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED68 REPERFUSION CATHETER; NRY

Catalog Number	THNDRRED68KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	02/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the m1, m2 and m3 segments of the middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68), a penumbra system red62 reperfusion catheter (red62), a neuron max 6f 088 long sheath (neuron max), a non-penumbra catheter, a non-penumbra microcatheter, a stent retriever and guidewires.During the procedure, the physician completed two passes using the red68.The physician then completed a third pass using the red62 and noted some vasospasm at the proximal m2 arteries.The patient was given 5 mg of cardene intraarterially.Post-op a dobbhoff tube was placed to administer nimodipine.The event was considered resolved on the same day.In the 24 hr computed tomography head (cth), it was noted that the patient's nihss score increased from 10 to 17.It was reported that this 7-point increase can be attributed to an evolving left mca infarct.Standard of care stroke pathway was continued, and the event was considered resolved on (b)(6) 2023.The vasospasm and evolving left infarct were adjudicated as adverse events by the cec chair with a possible relationship to the penumbra system, a possible relationship to the index procedure and a definite relationship to the index stroke.
Additional Manufacturer Narrative
The product was not returned for evaluation.Ischemia is included as a possible complication in the instructions for use (ifu) for the penumbra 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.This report is associated with mfr report number: 1.3005168196-2024-00009 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED68 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: 18460888
• Report Number: 3005168196-2024-00008
• Device Sequence Number: 3100555
• Product Code: NRY
• UDI-Device Identifier: 00815948024373
• UDI-Public: 815948024373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2024
• 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 Expiration Date: 06/21/2025
• Device Catalogue Number: THNDRRED68KIT
• Device Lot Number: F00001602
• 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: 12/11/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 41 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005