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

Catalog Number	RED62SKIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/30/2023
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a bmx96 access system (bmx96) a penumbra system red 43 reperfusion catheter (red43), a penumbra system red 68 reperfusion catheter (red68), a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity), non-penumbra coils, a penumbra engine (engine), a non-penumbra angiographic catheter, a non-penumbra glide catheter, a non-penumbra balloon catheter, a non-penumbra microcatheter, and guidewires.During the procedure, the physician used multiple guidewires and catheters to access the target vessel.The physician completed one pass using the red43.After completion of the pass, the red68 was advanced over the red43 and guidewire to the target location.The red43 and the guidewire were removed.Cyclic aspiration was initiated for two minutes using the red68.The red68 was removed from the patient and an angiography was performed through the bmx resulting in thrombolysis in cerebral infarction (tici) grade 2a with some faint filling of the m1 segment and some of the m2 territory.Therefore, the physician advanced a guidewire further distal and advanced the velocity with difficulty crossing the mid m1 segment over the guidewire.The red62 was then advanced over the velocity to the target location.The velocity and guidewire were removed, and the physician then aspirated for two minutes using the red62.After aspirating, the physician removed the red62 to perform an additional angiographic run using the bmx96.The angiography revealed contrast extravasation and subarachnoid hemorrhage (sah) appeared to be from the supraclinoid internal carotid artery (ica).It was reported that the perforation was likely caused by the guidewire.The patient was then intubated and general anesthesia was instituted.Next, two non-penumbra coils were placed across the perforation site sealing the right ica terminus.It was reported the initial angiographic run revealed flow through the anterior cerebral artery (aca).However, at the end of the procedure the ica territory on the right shut down.The patient developed a subsequent subarachnoid hemorrhage and early hydrocephalus.The patient expired on (b)(6) 2023.The intracranial hemorrhage and death were reported to have a possible relationship to the index procedure and the penumbra system.
Additional Manufacturer Narrative
Intracranial hemorrhage and death are included as possible complications in the instructions for use (ifu) for the penumbra system.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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.

• 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: 17374976
• Report Number: 3005168196-2023-00346
• Device Sequence Number: 17112494
• Product Code: NRY
• UDI-Device Identifier: 00815948024373
• UDI-Public: 815948024373
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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): 07/21/2023
• 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: 06/21/2025
• Device Catalogue Number: RED62SKIT
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/21/2023
• 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: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005