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

Catalog Number	RBYPODXL0870
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	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 splenic artery using a pod xl and a non-penumbra diagnostic catheter.It was noted that the patient's anatomy was tortuous.During the procedure, while advancing the pod xl through the diagnostic catheter, the physician experienced resistance.The physician continued advancing the pod xl against resistance and the pod xl became stuck.While retracting the pod xl with force, the embolization coil unintentionally detached within the distal length of diagnostic catheter.The pod xl pusher assembly was removed.The physician then removed the diagnostic catheter containing the detached embolization coil from the patient.The procedure was completed with a new diagnostic catheter and a pod coil and packing coil xl.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 fibers were fractured, and the embolization coil had offset coil winds near its proximal end.The fractured pe fibers likely contributed to the reported coil detachment during the procedure.If the pod xl is forcefully retracted against resistance, damage such as fractured pe fibers and offset coil winds on the embolization coil may occur.The reported tortuous anatomy may have contributed to the resistance during the procedure.Further evaluation revealed a kink near the proximal end of the pusher assembly.This damage is incidental to the complaint and 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: 22654583
• Report Number: 3005168196-2025-00249
• Device Sequence Number: 8762737
• Product Code: HCG
• UDI-Device Identifier: 00810169721735
• UDI-Public: 00810169721735
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: 04/16/2026
• Device Catalogue Number: RBYPODXL0870
• Device Lot Number: C00018023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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: 72 YR
• Patient Sex: Unknown