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

Catalog Number	400SWPC30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil confirmed 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 inside the pusher assembly distal detachment tip and the embolization coil was detached.If the swiftpac coil is retracted 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 not returned for evaluation.Further evaluation revealed kinks on the pusher assembly and the introducer sheath was loaded backward on the pusher assembly.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using swiftpac coils (swiftpac), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced a swiftpac through the microcatheter and into the target location.While repositioning the microcatheter, the swiftpac coil unintentionally detached.The physician used a wire to push the detached swiftpac into the aneurysm.The procedure was considered completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

• 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: 21612793
• Report Number: 3005168196-2025-00075
• Device Sequence Number: 12678091
• Product Code: HCG
• UDI-Device Identifier: 00815948029569
• UDI-Public: 00815948029569
• Combination Product (Y/N): N
• 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): 04/10/2025

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: 400SWPC30
• Device Lot Number: F00013127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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 Sex: Unknown