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

Catalog Number	RBYPODXL0655
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the varices using a pod xl, a non-penumbra coil, and a non-penumbra catheter.During the procedure, the physician successfully placed one non-penumbra coil in the target location.While advancing a pod xl, the physician noticed that the pod xl was too large for the target vessel.While retracting the pod xl, the physician kinked the pod xl pusher assembly.The physician continued to retract the pod xl and noticed that the pod xl unraveled.The pod xl was able to be completely removed.The procedure was completed at this point.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned pod xl confirmed that the embolization coil was unraveled and had offset coil winds.This damage typically occurs if the pod xl is retracted against resistance.Based on the reported complaint, the root cause of the resistance could not be determined.Further evaluation revealed that the pe fiber was fractured and the embolization coil was detached from the pusher assembly.Based on the reported event, this damage is incidental to the complaint, and the root cause could not be determined.The pusher assembly was not returned for evaluation.Therefore, the reported pusher assembly kink could not be confirmed.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 XL
• Common Device Name: 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 24077400
• Report Number: 3005168196-2026-00017
• Device Sequence Number: 13099073
• Product Code: KRD
• UDI-Device Identifier: 00810169721711
• UDI-Public: 00810169721711
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K250079
• 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): 02/11/2026

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: RBYPODXL0655
• Device Lot Number: F00017653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: 57 YR
• Patient Sex: Male