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

Catalog Number	RBYPODXL0655
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using pod xls, a non-penumbra braided catheter, and non-penumbra sheaths.During the procedure, the physician successfully placed a pod xl into the target location.While retracting the catheter, the physician observed under fluoroscopy the pod xl moved into an adjacent accessory artery.A snare device was used to reposition the pod xl but was unsuccessful.While retracting the snare device, the pod xl became damaged.The physician then decided to remove the embolization coil using the snare.No part of the pod xl was left in the patient.The physician then advanced a new pod xl to the target location and attempted to detach the coil.However, the embolization coil was still attached to the pusher assembly.The physician experienced resistance removing the pod xl.The pod xl was successfully removed.The embolization coil was damaged upon removal.The procedure was completed using a non-penumbra device, the same braided catheter, and the same sheaths.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 detached from its pusher assembly.Evaluation revealed the pe fibers were fractured and embolization coil unraveled.As the embolization coil was successfully placed and detached in the target location, the embolization coil damage likely occurred while snaring for removal from the patient.Penumbra devices 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23544193
• Report Number: 3005168196-2025-00364
• Device Sequence Number: 9284372
• Product Code: KRD
• UDI-Device Identifier: 00810169721711
• UDI-Public: 00810169721711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/20/2025

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 Expiration Date: 05/15/2026
• Device Catalogue Number: RBYPODXL0655
• Device Lot Number: C00018360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: 69 YR
• Patient Sex: Male