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	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned sendit delivery device (sendit) confirmed a fracture on the distal end and revealed that the device was tapered on a portion the distal fractured segment.If the sendit is retracted against resistance, the device may begin to stretch, taper and subsequently fracture.Based on the reported complaint, the loop in the patient¿s anatomy may have contributed to resistance during the procedure.The returned non-penumbra guidewire was also confirmed to be fractured on the distal length, and bends were present on the distal end.Evaluation of the returned red72 silver revealed stretching on the catheter.There was no reported allegation on the returned device.Therefore, this damage may be incidental, and the root cause could not be determined.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 m1 segment of the middle cerebral artery (mca) using a sendit delivery device (sendit), a penumbra red 72 reperfusion silver catheter (red72 silver), a benchmark bmx96 access system (bmx96), and a guidewire.It was reported that a loop was noticed in the internal carotid artery (ica).While advancing the bmx96 to the target location, the physician experienced resistance, but continued to use the bmx96.The physician advanced the red72 silver, sendit, and the guidewire through the bmx96 to the target location.The sendit and the guidewire were removed from the patient to initiate aspiration.The physician successfully completed one pass and noticed that the the distal end of the sendit and guidewire were aspirated along with the clot into the penumbra engine canister (canister).All parts of the sendit and the guidewire were removed from the patient, and the procedure was completed at this point.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: 25608981
• Report Number: 3005168196-2026-00212
• Device Sequence Number: 21310856
• Product Code: NRY
• UDI-Device Identifier: 00815948029996
• UDI-Public: 00815948029996
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/24/2026

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: F00018096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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: 80 YR
• Patient Sex: Female