MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Catalog Number	400PAC60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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 an embolization procedure for a carotid artery dissection using pac400 coils and a px slim delivery microcatheter (px slim).During the procedure, while advancing the pac400 to the target location, the pac400 unintentionally detached.It was reported that the detached coil was partially in the microcatheter and partially in the carotid artery.The coil pusher assembly was used to push the rest of the pac400 coil out of the px slim into the target vessel.The procedure was completed with more pac400 coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pac400 coil's pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, and the pull wire was inside the pusher assembly distal detachment tip.If the pac400 is manipulated against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching.Based on the reported complaint, the root cause of the resistance could not be determined.The complaint reported that the detached embolization coil was pushed into the target vessel using the pusher assembly.Further evaluation revealed kinks on the pusher assembly.This damage was incidental to the 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: PAC400 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: 22616618
• Report Number: 3005168196-2025-00243
• Device Sequence Number: 13152712
• Product Code: HCG
• UDI-Device Identifier: 00815948021358
• UDI-Public: 00815948021358
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 400PAC60
• Device Lot Number: F00013957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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 Sex: Unknown