MAUDE Adverse Event Report: PENUMBRA, INC. SENDIT DELIVERY DEVICE; 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	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) and the right a2 segment of the anterior cerebral artery (aca) using a sendit delivery device (sendit) and a penumbra system red72 reperfusion catheter (red72).It should be noted that the patient's carotid siphon was tortuous and the a1 had a sharp curve.During the procedure, the physician successfully completed one pass in the m1 using the red72 and the sendit.The sendit and red72 were then advanced to the a2 without difficulty.While removing the sendit from the red72, the physician experienced resistance and fractured the sendit inside the red72.The fractured sendit segment and the thrombus were then aspirated into the penumbra engine canister (canister) through the red72.At this point, the procedure was successfully completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21561054
• Report Number: 3005168196-2025-00072
• Device Sequence Number: 15768426
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: F00012484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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: 41 YR
• Patient Sex: Male