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

Catalog Number	RBY2C0312
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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 pod packing coil (packing coil), a ruby coil, and a lantern delivery microcatheter (lantern).During the procedure, a coil unintentionally detached.The physician then used a snare device to successfully retrieve the detached coil.It's currently unknown which coil unintentionally detached.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative: 1.Section b.Box 5.Describe event or problem 2.Section d.Box 4.Lot # 3.Section d.Box 4.Catalog # 4.Section d.Box 4.Expiration date 5.Section d.Box 4.Unique identifier 6.Section g.Box 4.Pma/510k number 7.Section h.Box 4.Device manufacture date please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.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 using a pod packing coil (packing coil), a ruby coil, and a lantern delivery microcatheter (lantern).During the procedure, the ruby coil unintentionally detached within the microcatheter.The physician then removed the lantern containing the detached ruby coil, which was subsequently flushed out.The procedure was completed using a new coil.There was no report of an adverse effect to the patient.

• 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 22080923
• Report Number: 3005168196-2025-00177
• Device Sequence Number: 15796343
• Product Code: HCG
• UDI-Device Identifier: 00814548018553
• UDI-Public: 00814548018553
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/14/2025

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: RBY2C0312
• Device Lot Number: F00011352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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 Age: 55 YR
• Patient Sex: Unknown