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

Catalog Number	400SWPC45
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the second returned swiftpac coil (swiftpac) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pe fibers were fractured.If the swiftpac is manipulated against resistance, the pe fibers may fracture causing the embolization coil to detach.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed that the coil winds were unraveled and wrapped around the non-penumbra stent retriever device.This damage likely occurred during removal of the detached coil from the procedure.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using swiftpac coils (swiftpacs) and a non-penumbra microcatheter.During the procedure, the physician advanced a swiftpac to the target location using the microcatheter.While retracting the swiftpac to reposition it, the physician noticed under fluoroscopy that the coil had unintentionally detached partially within the microcatheter and partially in the aneurysm.The physician then used a snare device to remove the detached swiftpac.The physician then advanced a second swiftpac of a different size to the target location using the same microcatheter.While retracting the swiftpac to reposition it, the physician noticed under fluoroscopy that the coil had unintentionally detached partially within the microcatheter and partially in the aneurysm.The physician then used a stent retriever to remove the swiftpac from the patient.The procedure was completed using the same microcatheter and another swiftpac.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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24405691
• Report Number: 3005168196-2026-00053
• Device Sequence Number: 12817894
• Product Code: HCG
• UDI-Device Identifier: 00815948029576
• UDI-Public: 00815948029576
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 400SWPC45
• Device Lot Number: F00018622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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: 43 YR
• Patient Sex: Female