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

Catalog Number	RBYPODXL1655
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	10/30/2025
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 ovarian vein using pod xls and a non-penumbra glide catheter.It was reported that the pod xl appeared to have no damage upon removal from the packaging.During the procedure, the physician placed one pod xl into the target vessel.While advancing the next pod xl, through the glide catheter, the physician experienced resistance, and the embolization coil unintentionally detached within the glide catheter.The glide catheter containing the detached embolization coil was removed.The glide catheter was readvanced into the patient.It was reported that the physician had difficulty advancing the next pod xl through the glide catheter.The glide catheter was removed, and a non-penumbra catheter was used.The same pod xl was readvanced and successfully placed into the target vessel.The procedure was completed using another pod xl and the same non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pod xl confirmed that the embolization coil was detached.Evaluation revealed that the proximal constraint sphere was inside the pusher assembly distal detachment tip.This indicates the coil detachment likely occurred due to fractured pe fibers.If the pod xl is retracted against resistance, damage such as fractured pe fibers and subsequent embolization coil detachment may occur.The detached embolization coil was not returned for evaluation.Based on the reported complaint, the root cause of the resistance during the procedure could not be determined.Further evaluation revealed that the pull wire was advanced distal from its initial position, and the pusher assembly was kinked throughout its length.This damage is incidental to the reported complaint.The pull wire advanced distally from its initial position likely occurred due to advancement against resistance.The pusher assembly kink may have occurred during packaging for return to penumbra.Penumbra coils 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: 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: 23623375
• Report Number: 3005168196-2025-00376
• Device Sequence Number: 8977613
• Product Code: HCG
• UDI-Device Identifier: 00810169721773
• UDI-Public: 00810169721773
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Catalogue Number: RBYPODXL1655
• Device Lot Number: F00017270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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: 42 YR
• Patient Sex: Female