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

Catalog Number	400SWPC30
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 right middle meningeal artery (mma) using a swiftpac coil (swiftpac), a swift coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed embolic agent in the target location.The physician advanced a swiftpac coil in the target location and attempted to detach it using the handle, but the swiftpac coil failed to detach.The swiftpac coil pusher assembly had separated but, the embolization coil was still attached.The physician made several attempts advancing and retracting the swiftpac to detach it but was unsuccessful.While removing the swiftpac coil, the physician experienced resistance and the swiftpac coil detached.Therefore, the physician used the pusher assembly of the swiftpac coil to push the detached coil successfully into the target location.The procedure to treat the right mma was completed and the remainder of the procedure to treat the left mma was completed using additional swiftpac coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was damaged and the pull wire was fractured at the proximal end of the pusher assembly.This likely occurred due to multiple detachment attempts during the procedure.Evaluation also revealed that the pull wire was in its initial position at the distal tip of the pusher assembly with an unknown residue inside the distal detachment tip.Based on the reported complaint, the unknown residue is likely the embolic agent placed in the target location.This may have caused the pull wire to become stuck in its initial position causing the initial detachment issue and subsequent detachment of the coil during retraction.Further evaluation revealed kinks throughout the pusher assembly.This damage is likely incidental to the reported 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: SWIFTPAC 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: 22929430
• Report Number: 3005168196-2025-00281
• Device Sequence Number: 9236110
• Product Code: HCG
• UDI-Device Identifier: 00815948029569
• UDI-Public: 00815948029569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• 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): 09/25/2025

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: 400SWPC30
• Device Lot Number: F00015701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: 76 YR
• Patient Sex: Male