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

Catalog Number	RBYPODXL0855
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the celiac artery using a pod xl coil (pod xl), a non-penumbra catheter, a non-penumbra sheath (6fr) and a guidewire.During the procedure, the physician obtained access from the left groin and advanced the guidewire and catheter through the sheath.While attempting to advance the pod xl, the physician reported difficulty advancing the pod xl due to vessel tortuosity and the turn from the aorta into the target artery.Under fluoroscopy, the physician noticed that the pod xl had unintentionally detached, with a small part of the coil remaining within the catheter.While attempting to remove the catheter, some part of the coil was pulled into the aorta.The physician then used a snare device to remove the pod xl.After the pod xl was removed, the physician proceeded by downsizing to a ruby coil, and packing coils using a lantern delivery microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod xl coil (pod xl) confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed the pet lock was separated, the pusher assembly was fractured, and the pull wire was retracted.Pet lock separation and fractured pusher assembly can both result in pull wire retraction and subsequent detachment of the coil.Based on the reported complaint, the root cause of the damage and reported detachment could not be determined.Further evaluation revealed bends along the pusher assembly and offset coil winds.This damage was incidental to the complaint, and the root cause could not be determined.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 COIL
• 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: 24702169
• Report Number: 3005168196-2026-00100
• Device Sequence Number: 10046756
• Product Code: KRD
• UDI-Device Identifier: 00810169721728
• UDI-Public: 00810169721728
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/17/2026

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: RBYPODXL0855
• Device Lot Number: F00017183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female