MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number	400SMTSFT0930
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a recoiling embolization procedure in the left anterior communicating artery (acom) using a smart coil (smart coil), a smart coil detachment handle (handle), a non-penumbra microcatheter, an intermediate catheter, and a guidewire.It was reported that the target vessel was previously coiled using stent support.During the procedure, the physician advanced the smart coil into the target vessel using the microcatheter and attempted to detach it using the handle.However, the smart coil failed to detach.The physician made additional attempts to detach the smart coil using a second handle and via manual detachment; however, the smart coil would still not detach.The physician then decided to remove the smart coil.While removing the smart coil, the coil unintentionally detached within the microcatheter.The physician used the pusher assembly of the smart coil to successfully push the detached smart coil into the aneurysm.The procedure was completed using additional smart coils and a new handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The smart coil was implanted in the patient; however, the pusher assembly is available for return.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• 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: 24530948
• Report Number: 3005168196-2026-00065
• Device Sequence Number: 10371678
• Product Code: HCG
• UDI-Device Identifier: 00814548014784
• UDI-Public: 00814548014784
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 400SMTSFT0930
• Device Lot Number: F110356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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: 67 YR
• Patient Sex: Female