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

Catalog Number	RBYPODXL0855
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod coil, ruby coil, pod xl coil (pod xl), a non-penumbra catheter, and a non-penumbra diagnostic catheter.It was noted that the target vessel was located on a bend within the splenic artery.During the procedure, the physician placed one pod coil and one ruby coil in the target vessel.While advancing a pod xl out of the diagnostic catheter, resistance was felt.The embolization coil would not form within the vessel.While torquing the 5fr diagnostic catheter and the pod xl, the physician noticed the pod xl was not responding to movement.The embolization coil fractured but was still connected to it¿s pusher assembly.Majority of the coil remained within the 5f catheter.It was reported that the entire pod xl was removed from the patient by hand.The procedure was completed with a new pod xl and the same diagnostic catheter.There was no report of an adverse effect to the patient.
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.

• 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: 25160940
• Report Number: 3005168196-2026-00165
• Device Sequence Number: 18294342
• Product Code: KRD
• UDI-Device Identifier: 00810169721728
• UDI-Public: 00810169721728
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/13/2026

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: F00020457
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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: 23 YR
• Patient Sex: Female