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

Catalog Number	400SWPC20
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using a swiftpac coil (swiftpac) and a non-penumbra microcatheter.During the procedure, while advancing the swiftpac through the microcatheter to the target location, the swiftpac unintentionally detached within the microcatheter.The microcatheter containing detached swiftpac was removed.The procedure was completed using another swiftpac and another non-penumbra microcatheter (headway duo 156cm).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly distal detachment tip was kinked, the pull wire was retracted from its alignment feature and the embolization coil was detached.If the swiftpac coil is manipulated against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching.Based on the reported event, the root cause of the resistance could not be determined.The detached embolization coil was returned stuck inside the hub of the non-penumbra microcatheter.Further evaluation revealed kinks on the pusher assembly and ovalization on the distal shaft of the non-penumbra microcatheter.This damage is incidental to the reported complaint and likely occurred during packaging for return to penumbra.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.

• 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: 22592946
• Report Number: 3005168196-2025-00244
• Device Sequence Number: 18393600
• Product Code: HCG
• UDI-Device Identifier: 00815948029675
• UDI-Public: 00815948029675
• 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
• 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): 07/24/2025

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: 400SWPC20
• Device Lot Number: F00015810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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: 77 YR
• Patient Sex: Female