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

Catalog Number	RBYPOD8
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization in the hypogastric artery using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil halfway out of the lantern, the pod coil unraveled and unintentionally detached.The physician then advanced a guidewire to trap the detached pod coil.The lantern containing the detached pod coil and the guidewire were removed.After removal of the detached pod coil, the guidewire, and the lantern, the physician noticed that the lantern was damaged at the distal end.The procedure was completed using another pod coil and another lantern.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization in the hypogastric artery using a pod coil and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil halfway out of the lantern, the pod coil unraveled and unintentionally detached.The physician then advanced a guidewire to trap the detached pod coil.The lantern containing the detached pod coil and the guidewire were removed.After removal of the detached pod coil, the guidewire, and the lantern, the physician noticed that the lantern was kinked at the distal end.The procedure was completed using another pod coil and another lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned pod coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the pull wire was in its initial position.If the pod coil is manipulated against resistance, the pusher assembly may elongate causing the embolization coil to detach.The kinks on the returned lantern may have contributed to resistance during the procedure.Further evaluation revealed kinks on the pusher assembly and offset coil winds.This damage is incidental to the reported complaint and may have 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: POD
• 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
• MDR Report Key: 23059248
• Report Number: 3005168196-2025-00296
• Device Sequence Number: 8581876
• Product Code: HCG
• UDI-Device Identifier: 00814548019635
• UDI-Public: 00814548019635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 11/07/2025

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: RBYPOD8
• Device Lot Number: F00011635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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 Age: 75 YR
• Patient Sex: Male