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

Catalog Number	RED72KIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra base catheter, and a guidewire via the right radial artery.It was noted that the patient had a tortuous anatomy.During the procedure, the red72 was advanced through the non-penumbra catheter but the physician encountered resistance in the internal carotid artery (ica).Therefore, the physician decided to remove both catheters.A guidewire was inserted for removal support.The red72 fractured at the distal length and the proximal length of the red72 was removed from the patient.The distal portion of the red72 remained in the patient.Multiple snare devices were used to try and retrieve the fractured piece of the red72; however, it was unsuccessful.The patient was transported to another facility for an open carotid endarterectomy where the fractured piece of the red72 was removed.Subsequently, the patient was admitted to the intensive care unit (icu).It was reported that the patient was recovering.
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 in the right m1 middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72) a non-penumbra base catheter, and a guidewire via the right radial artery.It was noted that the patient had a tortuous anatomy.During the procedure, the red72 was advanced through the non-penumbra catheter but the physician encountered resistance in the internal carotid artery (ica).Therefore, the physician decided to remove both catheters.A guidewire was inserted for removal support.The red72 fractured and the distal portion of the red72 remained in the patient.Multiple snare devices were used to try and retrieve the fractured piece of the red72; however, it was unsuccessful.The patient was transported to another facility for an open carotid endarterectomy where the fractured piece of the red72 was removed.Subsequently, the patient was admitted to the intensive care unit (icu).On 13-feb-2025, additional information was received that the patient is recovering in a skilled nursing facility and able to perform basic functions.
Additional Manufacturer Narrative
Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned penumbra system red 72 reperfusion catheter (red72) confirmed a fracture on the distal shaft.Further evaluation revealed stretching near the fracture.Kinks and ovalizations were present along the length of the catheter.If the red72 is advanced against resistance, damage such as kinks and ovalizations may occur.Subsequently, if the device is retracted against resistance, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed additional kinks and ovalizations on the proximal segment, and the coil winds were snared within a non-penumbra catheter.This damage was likely incidental and occurred during removal.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: 21305500
• Report Number: 3005168196-2025-00030
• Device Sequence Number: 18355088
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: H00005916
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female