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	Foreign Body In Patient (2687)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using swiftpac coil (swiftpac), a non-penumbra microcatheter, and a non-penumbra diagnostic catheter (5fr).During the procedure, the physician delivered microsphere particles in the target location.Next, the physician advanced the first swiftpac coil through the microcatheter but decided to retract the pusher assembly to reposition the swiftpac coil.While retracting the swiftpac coil, the physician experienced resistance and the swiftpac had unintentionally detached.It was reported the detached swiftpac coil was partially inside the microcatheter and partially in the vessel.Therefore, the physician removed the microcatheter and used a guidewire (.038) through the diagnostic catheter to push the detached swiftpac coil out from the common carotid artery into the external carotid artery.The procedure had ended at this point.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using swiftpac coil (swiftpac), a non-penumbra microcatheter, and a non-penumbra diagnostic catheter.During the procedure, the physician delivered microsphere particles in the target location.Next, the physician advanced the first swiftpac coil through the microcatheter but decided to retract the pusher assembly to reposition the swiftpac coil.While retracting the swiftpac coil, the physician experienced resistance and the swiftpac had unintentionally detached.It was reported the detached swiftpac coil was partially inside the microcatheter and partially in the vessel.Therefore, the physician removed the microcatheter and used a guidewire (.038) through the diagnostic catheter to push the detached swiftpac coil out from the common carotid artery into the external carotid artery.The procedure had ended at this point.

• 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: 21305168
• Report Number: 3005168196-2025-00029
• Device Sequence Number: 8903560
• 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): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 400SWPC30
• Device Lot Number: F00013127
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male