MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	05/10/2025
Type of Reportable Event	Death
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 to treat a large vessel occlusion (lvo) in the right internal carotid artery (ica) using a penumbra system red 72 reperfusion catheter (red72) and a benchmark bmx96 access system (bmx96).During the procedure, after performing a direct aspiration first-pass technique (adapt) for approximately ninety seconds, the physician retracted the red72 under aspiration and noticed that a distal segment of the red72 fractured within the right ica.The physician decided not to remove the fractured segment of the red72 and continued the procedure.The procedure was completed using another red72, the same bmx96, and a non-penumbra microcatheter with a thrombolysis in cerebral infarction (tici) score of 2a+.The physician then started a double anti-aggregation therapy.It was reported that the carotid branch that previously had slower flow, had increased flow due to the implanted part of the red72.The part of the red72 was not removed due to the patient's delicate medical condition.It was also reported that the branch of the right ica where the part of the red72 remained, later became re-occluded.The patient was also transferred to the intensive care unit (icu) for recovery.However, the patient later passed away.The cause of death is unknown.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed that the catheter was fractured.Evaluation revealed approximately 8 cm of stretching proximal to the fractured location.This is consistent with the device being retracted against resistance prior to fracture.If the red72 is retracted against resistance, damage such as stretching and subsequent fracture may occur.It was reported that the patient's anatomy was tortuous.This may have contributed to the resistance experienced during the procedure.The root cause could not be determined.Further evaluation revealed ovalization and kinks on the catheter shaft.This damage was likely incidental to the reported complaint and the root cause could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 22191148
• Report Number: 3005168196-2025-00182
• Device Sequence Number: 21042085
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED72KIT
• Device Lot Number: H00004440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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: Hospitalization; Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male