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

Catalog Number	400SWPC10
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned swiftpac coil pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the pull wire was in its initial position within the pusher assembly distal tip.If the swiftpac coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire causing the embolization coil to detach.Based on the reported event, the root cause of the resistance during procedure could not be determined.The detached embolization coil was not returned for evaluation.Further evaluation revealed kinks throughout the length of the pusher assembly.This damage is incidental to the complaint and may have occurred during packaging of device 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 to treat the left middle meningeal artery (mma).During the procedure, the physician placed microsphere particles in the target location using a non-penumbra microcatheter.The microcatheter was then removed and exchanged to a new microcatheter.The physician was advancing the swiftpac coil through the microcatheter and noticed the swiftpac coil had unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached swiftpac coil was removed.The procedure had ended at this point.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: 21437560
• Report Number: 3005168196-2025-00049
• Device Sequence Number: 19984606
• Product Code: HCG
• UDI-Device Identifier: 00815948029545
• UDI-Public: 00815948029545
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/21/2025

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: F00013951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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