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

Catalog Number	RED62SKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system red62 reperfusion catheter (red62), a penumbra system red 43 reperfusion catheter (red43), a bmx96 access system (bmx96), and a guidewire.During the procedure, the physician advanced the red43 and the red62 coaxially to the target location and completed two passes.While aspirating and manipulating the red62 and red43, the physician noticed under fluoroscopy that the red62 and red43 fractured in the m1 segment of the mca.The physician attempted to use a snare device without success.A non-penumbra balloon device was used to remove the fractured segments of the red62 and red43 from the patient.The procedure was completed using a new red62, a new red43, and the same bm96 resulting in thrombolysis in cerebral infarction (tici) grade 3.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red62 reperfusion catheter (red62) confirmed that the catheter was fractured and revealed stretching at the fracture site.If the catheter is retracted against resistance, damage such as stretching and a subsequent fracture may occur.Based on the reported event, the root cause of resistance during the procedure could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 and m2 segment of the middle cerebral artery (mca) using a penumbra system red62 reperfusion catheter (red62), a penumbra system red 43 reperfusion catheter (red43), a bmx96 access system (bmx96), and a guidewire.During the procedure, the physician advanced the red43 and the red62 coaxially to the target location.The physician completed two passes using the red43.While manipulating the red62 and red43, the physician noticed under fluoroscopy that the red62 and red43 fractured in the m1 segment of the mca.The physician attempted to use a snare device without success.A non-penumbra balloon device was used to remove the fractured segments of the red62 and red43 from the patient.The procedure was completed using a new red62, a new red43, and the same bm96 resulting in thrombolysis in cerebral infarction (tici) grade 3.There was no report of an adverse effect on the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on october 2, 2025: 1.Section b.Box 5.Describe event or problem.

• Brand Name: PENUMBRA SYSTEM RED 62 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 ; 5107483200
• MDR Report Key: 22693148
• Report Number: 3005168196-2025-00250
• Device Sequence Number: 12838807
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 00815948023536
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED62SKIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 10/02/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 68 KG