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

Catalog Number	RBYPODJ45
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	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned pod packing coil (packing coil) confirmed that the embolization coil was detached from its pusher assembly.Further evaluation revealed that the proximal constraint sphere was present on the returned embolization coil, and the embolization coil had offset coil winds.If the packing coil is manipulated against resistance during use, damage such as offset coil winds may occur.The reported kink in the non-penumbra microcatheter may have contributed to resistance during the procedure.The pusher assembly was not returned for evaluation, and therefore the root cause of the embolization coil detaching from its pusher assembly could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior gluteal artery using pod packing coils (packing coils), a non-penumbra coil, and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was highly tortuous and moderately calcified.During the procedure, the physician successfully placed the non-penumbra coil into the target vessel using the microcatheter.While advancing a packing coil in the microcatheter, the physician experienced resistance.Both the microcatheter and the packing coil were then removed from the patient and the physician found that the microcatheter was kinked.Therefore, the microcatheter was no longer used in the procedure.After inserting a second non-penumbra microcatheter of the same type into the patient, the physician attempted to advance the same packing coil into the microcatheter.While advancing the packing coil, it unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed from the patient, and the coil was then flushed out of the microcatheter.The procedure was completed using four additional packing coils, six non-penumbra coils, and the second microcatheter.There was no report of an adverse effect to the patient.

• 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 menezes ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23840058
• Report Number: 3005168196-2025-00404
• Device Sequence Number: 9835228
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: RBYPODJ45
• Device Lot Number: F00015569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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 Sex: Unknown