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

Catalog Number	400SWPC25
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the bilateral middle meningeal arteries (mma) using swiftpac coils (swiftpac), a swift coil detachment handle, midway 43 delivery catheter (midway 43), and a non-penumbra microcatheter.During the procedure, the physician detached four swiftpacs in the right mma using the handle.The physician then advanced a fifth swiftpac to the target location and attempted to detach it using the handle; however, the swiftpac coil did not detach.The physician subsequently used hemostats to manually detach the coil.The physician placed three swiftpac coils in the left mma using the microcatheter and midway 43.A fourth swiftpac was then successfully detached at the target location.After removal of the microcatheter from the target vessel, the swiftpac coil was observed to be within the midway 43 catheter.The midway 43 containing the detached coil was then removed from the patient.It was reported that a portion of the coil may have been within the microcatheter at the time of detachment, and that removal of the microcatheter may have contributed to movement of the coil into the midway 43.It was also reported that the midway 43 catheter was positioned very close to the target location.The procedure was considered completed.The final diagnostic run confirmed complete occlusion of the mma.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24226658
• Report Number: 3005168196-2026-00034
• Device Sequence Number: 9238333
• Product Code: HCG
• UDI-Device Identifier: 00815948029682
• UDI-Public: 00815948029682
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/30/2026

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: 400SWPC25
• Device Lot Number: F00016331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: 79 YR
• Patient Sex: Male