MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER; NRY

Catalog Number	RED43160
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red 43 reperfusion catheter (red43), penumbra system red 62 reperfusion catheter (red62), a benchmark bmx96 access system (bmx96), and a 9fr non-penumbra short sheath.During the procedure, the physician was experiencing resistance advancing the red43 into the red62.The physician advanced the red62 containing the red43 and a guidewire together into the proximal face of the clot in the distal m2 and m3 angular branch of the left mca.While retracting the red43 and guidewire, the physician noticed the red43 had fractured and the distal segment of the red43 remained the intracranial vasculature.It was reported the distal end of the red43 was in the supraclinoid internal carotid artery (ica) and the proximal end of the red43 was in the common carotid.The physician initiated aspiration using the red62 for approximately two minutes.The red62 was slowly retracted under continuous aspiration while monitoring the flow in the tubing.The physician removed the red62 and the bmx96 was double flushed with saline.The bmx96 was retracted into the distal left ica and an angiogram was performed to locate the proximal end of the fractured red43 segment.The physician made multiple attempts using a snare device through the bmx96 and was unable to remove the fractured segment of the red43.Therefore, the physician removed and exchanged to a different snare device.The snare device was used to capture the fractured segment of the red43 into the lumen of the bmx96.The bmx96 containing the snare device and the fractured segment of the red43 was successfully removed together as a unit.The procedure was completed at this point.Post imaging was performed through a diagnostic catheter.There was no report of an adverse effect to the patient.
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 red 43 reperfusion catheter (red43) confirmed that the catheter was fractured.Stretching was also found at the fractured location and other locations on the red43.If the red43 is retracted against resistance, damage such as stretching and subsequent fracture may occur.The kinks on the red62 may have contributed to resistance during the procedure.Further evaluation revealed a kink on the distal fractured segment.The kink is incidental to the reported complaint and likely occurred during snaring.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 43 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): ONE PENUMBRA PLACE; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22205955
• Report Number: 3005168196-2025-00200
• Device Sequence Number: 17829175
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 00815948025745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222808
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: RED43160
• Device Lot Number: F00015235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 73 KG