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

Catalog Number	RED72
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a neuron max 6f 088 long sheath (neuron max), a penumbra system red 72 reperfusion catheter (red72), a microcatheter, and a.35 guidewire.During the procedure, while advancing the red72 through the neuron max using the microcatheter and guidewire, the red72 became stuck in the ophthalmic artery.While attempting to pull the red72 back, the physician noticed under fluoroscopy that the mid-shaft of the red72 was stretched and unraveled.Therefore, the neuron max containing the damaged red72 was removed.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68) and the same neuron max to make three passes.It was reported that tici 2b was achieved.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 reperfusion catheter (red72) confirmed the reported stretching and revealed a fracture at the stretched location.If the red72 is retracted against resistance, damage such as stretching and a subsequent fracture may occur.Further evaluation revealed ovalization distal to the stretched region.The ovalization may have occurred during advancement against resistance during the procedure and may have contributed to additional resistance during removal of red72 causing the device to stretch and subsequently fracture.The root cause of initial resistance during the procedure could not be determined.Evaluation also revealed kinks on the catheter shaft.The kinks are likely incidental to the complaint and may have occurred during packaging of device for return to penumbra.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: 21921788
• Report Number: 3005168196-2025-00143
• Device Sequence Number: 9031391
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 00815948023918
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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 Expiration Date: 01/23/2026
• Device Catalogue Number: RED72
• Device Lot Number: H00001965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: 70 YR
• Patient Sex: Male