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

Catalog Number	RBYPOD6
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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gda using pod coils, ruby coils, packing coils, and a non-penumbra microcatheter.During the procedure, while advancing pod coil through the microcatheter the hospital technician experienced resistance.While retracting the pod coil, the coil unintentionally detached within the microcatheter.The microcatheter containing the detached embolization coil was removed.A new microcatheter was opened and multiple packing and ruby coils were placed in the target vessel.While advancing a ruby coil into the target vessel, the coil was too large and would not fit in the vessel.While retracting the ruby coil, the hospital technician kinked the pusher assembly.The ruby coil was removed.While advancing a new ruby coil into the target vessel, the coil would not fully enter the vessel, and the ruby coil was retracted.Multiple attempts were made to re-advance the coil into the vessel; however, the hospital technician kinked the ruby coils pusher assembly.Therefore, the ruby coil was removed.The procedure was completed with packing coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 ; 5107483200
• MDR Report Key: 23623480
• Report Number: 3005168196-2025-00377
• Device Sequence Number: 10072882
• Product Code: HCG
• UDI-Device Identifier: 00814548019611
• UDI-Public: 00814548019611
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: RBYPOD6
• Device Lot Number: F00005926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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: 52 YR
• Patient Sex: Male