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

Catalog Number	400SWPC60
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
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 the three lots were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) in m3/m4 segment of the middle cerebral artery (mca) using swiftpac coil (swiftpac), a non-penumbra microcatheter.During the procedure, the physician placed a non-penumbra coil in the target vessel.Next, while advancing a swiftpac into the vessel, the coil unintentionally detached.It was reported the swiftpac detached mostly in the vessel with 5 to 10cm in the mca.The physician made multiple attempts to reposition the end segment of swiftpac from the mca into the m3/m4, but the attempts were not successful.Therefore, the swiftpac was left in place.The procedure was aborted.The current patient status is unknown.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 06/10/2025: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) in m3/m4 segment of the middle cerebral artery (mca) using swiftpac coil (swiftpac), a non-penumbra microcatheter.During the procedure, the physician placed a non-penumbra coil in the target vessel.Next, while advancing a swiftpac into the vessel, the coil unintentionally detached.It was reported the swiftpac detached mostly in the vessel with 5 to 10cm in the mca.The physician made multiple attempts to reposition the end segment of swiftpac from the mca into the m3/m4 using the coils pusher wire, a guidewire, and microcatheter, but the attempts were not successful.Therefore, the swiftpac left in place.The procedure was aborted.The current patient status is unknown.

• 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: 22172202
• Report Number: 3005168196-2025-00194
• Device Sequence Number: 7788782
• Product Code: HCG
• UDI-Device Identifier: 00815948029583
• UDI-Public: 00815948029583
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 400SWPC60
• Device Lot Number: F00014139
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 58 YR
• Patient Sex: Male