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

Catalog Number	RBYPODXL0410
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the feeder vessel off of the rue fistula using a packing coil xl, pod xls, and a non-penumbra glide catheter.During the procedure, one pod xl was implanted into the target vessel.The next packing coil xl pusher assembly was noticed to be kinked upon removal of the packaging.The damage to the packing coil xl was noticed prior to use; therefore, it was not used in the procedure.Another pod xl was advanced into the glide catheter.Difficulty was experienced when tracking the pod xl through the catheter.It was unable to be advanced the length of the glide catheter.The physician retracted the pod xl, and the embolization coil unintentionally detached within the glide catheter.The glide catheter containing the detached pod xl was removed.The procedure was completed at this point.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: HCG, 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: 23735506
• Report Number: 3005168196-2025-00390
• Device Sequence Number: 13183455
• Product Code: HCG
• UDI-Device Identifier: 00810169721667
• UDI-Public: 00810169721667
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/05/2025

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: 05/20/2026
• Device Catalogue Number: RBYPODXL0410
• Device Lot Number: C00018422
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: 54 YR
• Patient Sex: Female