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

Catalog Number	400SWPC60
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2025
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.Please note that three lot numbers were provided: f00014325, f00014343, and f00014297.It is unknown which lot number is associated with the reported event.1.Lot #: f00014325, manufacture date: 2024-10-25, expiration date: 2029-10-24.2.Lot #: f00014343, manufacture date: 2024-10-29, expiration date: 2029-10-28.3.Lot #: f00014297, manufacture date: 2024-10-23, expiration date: 2029-10-22.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) using a swiftpac coil (swiftpac), non-penumbra coils, and a flow diverter.During the procedure, the physician placed two non-penumbra coils and nine swiftpac coils in the target location.A flow diverter was then placed in the vessel.Next, after advancing approximately twenty centimeters of a swiftpac coil in the vessel, the physician noticed the swiftpac coil started to run behind the flow diverter.The physician attempted to retract the swiftpac coil, but experienced resistance and the swiftpac coil unintentionally detached in the vessel.It was reported that two stents were placed to pin the swiftpac coil against the vessel wall.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

• 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: 22035439
• Report Number: 3005168196-2025-00166
• Device Sequence Number: 8641670
• Product Code: HCG
• UDI-Device Identifier: 00815948029583
• UDI-Public: 00815948029583
• 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
• 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): 05/16/2025

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: 400SWPC60
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown