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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle meningeal artery (mma) using swiftpac coils (swiftpac), a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician placed embolization particles in the target vessel.The physician then advanced a swiftpac to the target location using the microcatheter and decided to reposition the swiftpac.It was reported that the physician experienced resistance advancing and retracting the swiftpac.While retracting, the embolization coil unintentionally detached within the microcatheter.The microcatheter containing the detached embolization coil was removed.While advancing the next swiftpac through the microcatheter, the swiftpac pusher assembly kinked.The swiftpac was removed.The procedure was completed at this point.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.
Additional Manufacturer Narrative
Evaluation of the first returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the pull wire was in its initial position inside the distal detachment tip of the pusher assembly.If the swiftpac 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.It was reported that embolization particles had been placed in the target vessel.This may have contributed to the resistance during the procedure.Further evaluation revealed kinks on the pusher assembly and offset coil winds along the embolization coil.This damage is incidental to the reported complaint and may have occurred due to advancement against resistance and during packaging for return to penumbra.Penumbra coils are 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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 mfr report and is being included on this follow-up #02: 1.Section h.Box 2.If follow-up, what type?.

• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23981463
• Report Number: 3005168196-2026-00004
• Device Sequence Number: 21508752
• Product Code: HCG
• UDI-Device Identifier: 00815948029583
• UDI-Public: 00815948029583
• 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
• 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,Followup
• Report Date (Section B): 01/29/2026

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: F00015579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026; Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/28/2026; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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 Sex: Unknown