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

Catalog Number	RBY2C0420
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, the ruby coil unintentionally detached within the lantern.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroepiploic artery using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, the ruby coil was advanced to the target vessel using the lantern.The physician noticed that the position of the ruby coil was not perfect and decided to re-position it.While pulling the ruby coil back, the ruby coil unintentionally detached within the lantern.Therefore, the lantern containing the detached ruby coil was removed.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2026-00037: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the pull wire was in its initial position, and the proximal constraint sphere was intact on the detached embolization coil.If the ruby coil is retracted against resistance during use, the pusher assembly may elongate beyond the reach of the pull wire causing the embolization coil to detach.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed a kink on the pusher assembly and offset coil winds along the embolization coil.This damage was incidental to the reported 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: RUBY 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: 24239349
• Report Number: 3005168196-2026-00037
• Device Sequence Number: 8980481
• Product Code: HCG
• UDI-Device Identifier: 00814548018591
• UDI-Public: 00814548018591
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173614
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: RBY2C0420
• Device Lot Number: F00014564
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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