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	05/12/2025
Type of Reportable Event	Malfunction
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 non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced the majority of the swiftpac into the target location.It was reported that the physician decided to remove the swiftpac for a shorter coil.While retracting the swiftpac pusher assembly, the swiftpac did not retract.The swiftpac had unintentionally detached within the microcatheter.After removing the swiftpac pusher assembly, the physician used a 3cc syringe to push the detached swiftpac out of the microcatheter and into the right internal maxillary artery (imax).The physician deemed it was safe to leave the detached swiftpac in the imax.The procedure was completed at this point.
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 intact and the pull wire was in its initial position.If the swiftpac is retracted against resistance, the pusher assembly may elongate causing the embolization coil to detach.The root cause of the resistance during the procedure could not be determined.Further evaluation revealed kinks on the pusher assembly.This damage is incidental to the reported complaint and likely occurred during packaging of the device for return to penumbra.Penumbra devices 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: 22158778
• Report Number: 3005168196-2025-00191
• Device Sequence Number: 7266092
• Product Code: HCG
• UDI-Device Identifier: 00815948029583
• UDI-Public: 00815948029583
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

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: 400SWPC60
• Device Lot Number: F00014139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Female