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

Catalog Number	RBYPODXL1055
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	10/17/2025
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 varices using a pod xl and a non-penumbra catheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician obtained direct stick access in the abdomen.The pod xl was advanced to the distal end of the catheter, but while attempting to advance the pod xl in the vein, the physician was experiencing resistance and decided to remove the pod xl.Then, while removing the pod xl, the coil unintentionally detached inside the catheter.Therefore, the catheter containing the detached pod xl was removed together as a unit.The procedure was completed using new pod xls, packing coil xls, pod coils, and a new 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 pe fiber was fractured, and the proximal constraint sphere was missing at the proximal end of the embolization coil.This type of damage typically occurs if the device is retracted against resistance during use.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed that the embolization coil had offset coil winds.This damage is incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are 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: 23513535
• Report Number: 3005168196-2025-00359
• Device Sequence Number: 9667241
• Product Code: HCG
• UDI-Device Identifier: 00810169721742
• UDI-Public: 00810169721742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/13/2025

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: RBYPODXL1055
• Device Lot Number: F00017927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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: 32 YR
• Patient Sex: Male