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

Catalog Number	RED72SDKIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 reperfusion catheter (red72) confirmed that the catheter was fractured.The complaint indicated that resistance was experienced during removal of the red72 due to a kink in the guide catheter.If the red72 is retracted against resistance, damage such as a fracture may occur.The distal fractured segment was not returned for evaluation.Due to the return condition, the red72 was unable to be functionally tested.Further evaluation revealed that the strain relief was stretched and ovalization on the catheter shaft.This damage was incidental to the reported complaint.The ovalization may have occurred during handling of the device during removal from the guide catheter.The root cause of the stretched strain relief could not be determined.Penumbra devices are visually 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) and middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72) a sendit delivery device (sendit), and a guide catheter.It was reported that the ica segment was highly tortuous.During the procedure, the physician had difficulty tracking the sendit to the target location but was able to do so.The physician completed several passes in the target location with the red72.When removing the red72, the physician encountered resistance.When the red72 was removed from the patient, the physician noticed it was fractured.The physician then removed the guide catheter and noticed it was kinked.The physician believed the red72 damage was due to the kink in the guide catheter.The procedure was completed.There was no report of an adverse effect to the patient.

• 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: 22216891
• Report Number: 3005168196-2025-00205
• Device Sequence Number: 8132289
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: RED72SDKIT
• Device Lot Number: F00015071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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 Sex: Female
• Patient Weight: 68 KG