MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER; NRY

Catalog Number	RED43160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in the left m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a penumbra system red 43 reperfusion catheter (red43), a neuron max 088 6f long sheath (neuron max), a non-penumbra stent retriever, and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician completed three passes using the red62, and one pass using the red43.Thrombolysis in cerebral infarction (mtici) score of 2a was achieved.The physician then attempted to use a stent retriever; however, the stent retriever could not advance past the clot in the left m2 segment.It was reported that a dissection was noted in the left internal carotid artery (ica) and it was past the level of neuron max.The physician performed balloon angioplasty to treat the left ica dissection with a brisk flow return to the ica.A mtici score of 2a was achieved.On (b)(6) 2024, post-procedure day one (pod1), the left ica dissection was considered resolved.On (b)(6) 2024, the patient was discharged to a skilled nursing facility.On (b)(6) 2024, the patient exited the study.On (b)(6) 2024, the cec chair adjudicated the left ica dissection as a serious adverse event with a definite relationship to the index procedure and a probable relationship to the penumbra system.

• Brand Name: PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER
• Common Device Name: NRY
• 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: 20764235
• Report Number: 3005168196-2024-00389
• Device Sequence Number: 21148290
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 00815948025745
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K222808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: RED43160
• Device Lot Number: F00011703
• 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: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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: 75 YR
• Patient Sex: Female