MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using a penumbra coil 400 (pc400), a penumbra coil 400 detachment handle (handle), and an access25 delivery microcatheter (access25).During the procedure, the physician attempted to detach the pc400 nine times using the handle, but the pc400 would not detach.It was reported that the pc400 pusher assembly detachment zone was stuck in the handle and could not be removed.The physician then pulled the pc400 pusher assembly detachment zone with the handle attached to manually detach the pc400 without success.The pc400 was then advanced and retracted within the access25, but the pc400 would not detach.The physician advanced and retracted the access25 to reposition, but the pc400 would not detach.After multiple attempts to detach the pc400, the physician decided to remove the pc400.While retracting the pc400, the pc400 unintentionally detached within the access25.The physician then used the pc400 pusher assembly to gently push the detached pc400 into the target location.The procedure was completed using two additional pc400s, another handle, and the same access25.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra coil 400 (pc400) confirmed that the pusher assembly was fractured on its proximal end, and the pull wire and pull tube was returned stuck inside the returned handle.The pusher assembly fractures likely occurred during the manual detachment attempts during the procedure.The pull wire and pull tube being stuck inside handle typically occurs due to repeated actuation of the handle during a detachment attempt.Further evaluation revealed an ovalization on the distal end of the pusher assembly, and the embolization coil was detached.The ovalization on the pusher assembly may be incidental to the complaint and the root cause could not be determined.Penumbra coils are visually 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 COIL 400
• 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: 21590417
• Report Number: 3005168196-2025-00074
• Device Sequence Number: 15541228
• Product Code: HCG
• UDI-Device Identifier: 00814548018539
• UDI-Public: 00814548018539
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/12/2025

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: 4004C0820
• Device Lot Number: C00000086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2019
• 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: 75 YR
• Patient Sex: Female