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

Catalog Number	400SWPC10
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coils (swiftpac) confirmed kinks on the pusher assembly and that the embolization coil was detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pull wire was in its initial position inside the pusher assembly distal detachment tip.If the swiftpac coil is advanced against resistance, damage such as kinks on the pusher assembly may occur.Subsequently, if the swiftpac coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.The detached embolization coil was reported to have been left inside the intended vessel.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using swiftpac coils (swiftpac), and a non-penumbra microcatheter.During the procedure, the physician successfully implanted three swiftpac coils.While advancing the next swiftpac, the swiftpac pusher assembly slightly kinked.The physician decided to remove and resheath the swiftpac.While retracting, the physician experienced resistance, and the swiftpac unintentionally detached in the intended vessel.The physician decided to leave the swiftpac in place.The procedure was completed using non-penumbra coils and the same microcatheter.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: 21551541
• Report Number: 3005168196-2025-00069
• Device Sequence Number: 4475325
• Product Code: HCG
• UDI-Device Identifier: 00815948029545
• UDI-Public: 00815948029545
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/07/2025

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: 400SWPC10
• Device Lot Number: F00014189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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: 72 YR
• Patient Sex: Female