MAUDE Adverse Event Report: PENUMBRA, INC. POD400; HCG, KRD

Catalog Number	400POD4
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod400 coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact at the proximal end of the pusher assembly, and the pull wire was inside the distal tip of the pusher assembly.If the device is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching.Based on the reported complaint, the moderately tortuous anatomy may have contributed to resistance during the procedure.Further evaluation revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for both lots 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 posterior auricular artery using a pod400 coil and an access25 delivery microcatheter (access25).It should be noted that the patient's anatomy was moderately tortuous.During the procedure, the physician advanced the pod400 to the target vessel using the access25.While repositioning the pod400, it unintentionally detached with half the coil in the target vessel and half inside the access25.The physician then pushed the detached pod400 into the target vessel using the pusher assembly.The procedure was completed using a pod packing coil (packing coil) and the same access25.There was no report of an adverse effect to the patient.

• Brand Name: POD400
• 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: 22473124
• Report Number: 3005168196-2025-00234
• Device Sequence Number: 8113086
• Product Code: HCG
• UDI-Device Identifier: 00815948020337
• UDI-Public: 00815948020337
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/10/2025

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: 400POD4
• Device Lot Number: F00012222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: 37 YR
• Patient Sex: Female