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	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (packing coils), a ruby coil, non-penumbra coils and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was moderately tortuous and moderately calcified.During the procedure, the physician successfully placed four non-penumbra coils, one ruby coil and four packing coils into the target vessel using the microcatheter.While advancing another packing coil through the microcatheter, the packing coil could not be advanced at the distal end of the microcatheter.Upon attempting to retract the packing coil, it unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached packing coil was removed.The procedure was completed using a new packing coil and the same microcatheter.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
Please note that the following sections are being updated based on additional information provided by the distributor on 12/02/2025: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Medical device problem code 1.Evaluation of the returned pod packing coil (packing coil) could not confirm the reported advancement issue.Evaluation revealed a functional device.During evaluation, the packing coil was advanced through a demonstration lantern without an issue.Therefore, the root cause of the reported complaint 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.Note: based on the additional information received, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (packing coil), a ruby coil, non-penumbra coils and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was moderately tortuous and moderately calcified.During the procedure, the physician successfully placed four non-penumbra coils, one ruby coil and four packing coils into the target vessel using the microcatheter.While advancing another packing coil through the microcatheter, the physician experienced resistance at the distal end of the microcatheter and was unable to advance the packing coil any further.Therefore, both the microcatheter and the packing coil were removed.The procedure was completed using a new packing coil and the same 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23525909
• Report Number: 3005168196-2025-00362
• Device Sequence Number: 15738487
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: F00015973
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Sex: Unknown