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

Catalog Number	RBYPODXL1055
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in two varices of the left renal vein using a pod xl coil (pod xl), a non-penumbra catheter (4fr), and a non-penumbra sheath (7fr).The physician successfully placed multiple coils in the first varix.The catheter was then repositioned to the second varix and placed one non-penumbra coil.While advancing the pod xl through the catheter, the physician experienced resistance causing the coil's pusher assembly to kink.Subsequently, the pod xl unintentionally detached within the catheter.The catheter was removed; however, the embolization coil remained within the sheath.The sheath containing the embolization coil was removed from the patient.Access was lost and the procedure was considered completed.There was no report of an adverse effect to the patient.

• 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: 25367141
• Report Number: 3005168196-2026-00183
• Device Sequence Number: 9808673
• Product Code: KRD
• UDI-Device Identifier: 00810169721742
• UDI-Public: 00810169721742
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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: RBYPODXL1055
• Device Lot Number: F00020662
• 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: 05/05/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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: 65 YR
• Patient Sex: Male