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

Catalog Number	RBYLP0105
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	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ileocolic artery using ruby coil lps and a non-penumbra microcatheter.During advancement of a ruby coil lp through the microcatheter, the physician noted resistance described as a gritty feel, and the coil did not fully advance beyond the distal end of the microcatheter.During retraction, the ruby coil lp unintentionally detached within the microcatheter.The microcatheter containing the detached embolization coil was removed from the patient.It was reported that the same issue occurred with a second ruby coil lp.The microcatheter containing the second detached embolization coil was also removed.The procedure was subsequently completed using a new ruby coil lp and the same microcatheter.There were no reported adverse effects 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.

• Brand Name: RUBY COIL LP
• 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: 24849037
• Report Number: 3005168196-2026-00120
• Device Sequence Number: 17558809
• Product Code: HCG
• UDI-Device Identifier: 00815948025967
• UDI-Public: 00815948025967
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• 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): 06/10/2026

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: RBYLP0105
• Device Lot Number: F00018970
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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: 85 YR
• Patient Sex: Female