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

Catalog Number	RBYPODJ15
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left tibial artery using a pod packing coil (packing coil), a ruby coil detachment handle (handle), a lantern delivery microcatheter (lantern), a non-penumbra catheter, and a non-penumbra sheath.During the procedure, the physician placed two embolization coils in the target location.A new packing coil was advanced to the target location, and the physician attempted to detach the packing coil using the handle, but the packing coil would not detach.It was reported that the packing coil pusher assembly was stuck within the handle.The physician then removed the packing coil pusher assembly and lantern from the patient.The packing coil had unknowingly detached within the non-penumbra catheter.While advancing a new lantern through the non-penumbra catheter, the physician met resistance at the distal end.Imaging revealed the detached coil had detached within the non-penumbra catheter.The catheter containing the detached embolization coil was removed.The procedure was considered completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned pod packing coil (packing coil) confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that pusher assembly pull tube and pull wire were stuck inside the returned handle.The embolization coil detachment was likely due to the separation of the pet lock and retraction of the pull wire out of the pusher assembly distal tip.The pusher assembly was not returned for evaluation; therefore, the root cause could not be determined.Further evaluation revealed that the pe fibers were fractured, and the coil winds were unraveled.This damage is likely incidental to the reported complaint and may have occurred during removal of the detached coil from the non-penumbra microcatheter during the procedure.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 PACKING COIL
• 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: 23503554
• Report Number: 3005168196-2025-00357
• Device Sequence Number: 8904176
• Product Code: HCG
• UDI-Device Identifier: 00814548017648
• UDI-Public: 00814548017648
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170852
• 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): 01/15/2026

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: RBYPODJ15
• Device Lot Number: F00016922
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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: Male