MAUDE Adverse Event Report: PENUMBRA, INC. SENDIT DELIVERY DEVICE; NRY

Catalog Number	RED72SDKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned sendit delivery device (sendit) confirmed it was fractured.If the sendit is forcefully retracted against resistance, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance could not be determined.Evaluation of the returned penumbra system red72 silver reperfusion catheter (red72 silver) revealed consecutive kinks on the catheter.This damage likely occurred due to retracting of the sendit against resistance.There was no alleged complaint against the returned red72 silver.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using the penumbra system red 72 silver reperfusion catheter (red72 silver), a sendit delivery device (sendit), a neuron max 6f 088 sheath (neuron max), and a guidewire.While removing the sendit from the red72 silver, the physician experienced resistance.The physician continued to retract the sendit and observed that the sendit was fractured under fluoroscopy.The red72 silver containing the sendit was removed.No part of the sendit was in the patient.The procedure was completed with one pass using another red72 silver, another sendit, the same neuron max, and the same guidewire.There was no report of an adverse effect to the patient.

• Brand Name: SENDIT DELIVERY DEVICE
• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 25684742
• Report Number: 3005168196-2026-00221
• Device Sequence Number: 9656051
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K242104
• 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): 07/01/2026

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: F00018396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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: 74 YR
• Patient Sex: Male