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

Catalog Number	400SMTHXSFT0306
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.It should be noted that the patient's anatomy was mildly tortuous and mildly calcified.During the procedure, the physician successfully implanted a smart coil into the target location using the handle.After advancing another smart coil into the target vessel, the physician attempted to detach it using the handle; however, the smart coil failed to detach.The physician removed and reinserted the pusher assembly of the smart coil into the handle and made another attempt to detach it using the handle; however, the smart coil still did not detach.The physician attempted to manually detach the smart coil, but the smart coil still did not detach.While attempting to retract the smart coil and remove it from the patient, the coil unintentionally detached.However, the smart coil was able to be removed from the patient manually.The procedure was completed by using a non-penumbra coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra smart coil (smart coil) revealed that the pet lock was intact on the proximal end of the pusher assembly.This indicates that there was no proper attempt to detach the embolization coil.If the pet lock is not separated during the detachment attempt, the embolization coil will not detach.Evaluation also revealed that the pull wire was in its original position, and the embolization coil was detached.If the smart coil is retracted against resistance, the pusher assembly may elongate causing the embolization coil to detach.However, based on the reported complaint and the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed kinks along the pusher assembly and offset coil winds.This damage is likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils 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 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22908935
• Report Number: 3005168196-2025-00282
• Device Sequence Number: 8851794
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• 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,Followup
• Report Date (Section B): 09/10/2025

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: 400SMTHXSFT0306
• Device Lot Number: F00000490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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 Sex: Unknown