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

Catalog Number	RBYPOD10
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	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat portal vein varices using a pod coil, a lantern delivery microcatheter (lantern), and a non-penumbra glide catheter.During the procedure, while advancing the pod coil through the lantern, the physician experienced resistance and noticed the coil would not exit the lantern.The physician tried to remove the pod coil, but it became stuck.The physician attempted to remove the pod coil with hemostats by pining the coil wire within the glide catheter, however, the coil's pusher wire fractured and the pod coil detached within the lantern.Therefore, the glide catheter and lantern containing the pod coil were removed.The procedure was completed with a new lantern and another pod coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pe fibers were fractured.This damage likely contributed to the reported coil detachment issue during the procedure.If the pod coil is forcefully retracted against resistance, the pe fibers may fracture causing the embolization coil to detach.Further evaluation revealed pusher assembly was fractured.This type of damage typically occurs due to forceful retraction of the device against resistance during use.The root cause of resistance during the procedure could not be determined.Further evaluation of the device revealed that the embolization coil had offset coil winds, and the pusher assembly had bends.The root cause of the offset coil winds could not be determined; however, the offset coil winds may have contributed to resistance during removal of the pod coil.The kinks on the pusher assembly were incidental to the complaint.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 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: 21973369
• Report Number: 3005168196-2025-00155
• Device Sequence Number: 15745838
• Product Code: HCG
• UDI-Device Identifier: 00814548019659
• UDI-Public: 00814548019659
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 06/18/2025

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
• Device Catalogue Number: RBYPOD10
• Device Lot Number: F00012812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: 36 YR
• Patient Sex: Male