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

Catalog Number	RBY4C0620
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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 in the common hepatic artery using ruby coils, a non-penumbra microcatheter, and an access sheath.The physician advanced the access sheath into the coeliac trunk followed by a stent across the neck of the aneurysm.While advancing the fourth ruby coil through the microcatheter, the physician experienced resistance and the coil unintentionally detached within the microcatheter.The microcatheter containing the coil was removed from the patient under aspiration.On the back table, the physician pulled the coil out of the microcatheter, which resulted in the coil to unravel.A new microcatheter of the same type was then introduced to the patient and a diagnostic catheter was used as support.Four additional coils were then implanted in the target location.While advancing the final ruby coil, the coil unintentionally detached within the microcatheter.The physician then used a guidewire to push the detached ruby coil into the target location and removed the microcatheter.The physician began to remove the diagnostic catheter and observed that the proximal end of the ruby coil moved when the diagnostic catheter was retracted.The ruby coil seemed to be stuck in the diagnostic catheter.The physician then used another guidewire to remove the ruby coil from the diagnostic catheter.At this point, the physician was satisfied with the outcome of the procedure and it was considered completed.There was no report of an adverse effect to the patient.A follow-up computed tomography (ct) scan will be performed at a later date to assess the location of the proximal end of the ruby coil.

• 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: 25627490
• Report Number: 3005168196-2026-00218
• Device Sequence Number: 9093944
• Product Code: HCG
• UDI-Device Identifier: 00814548018355
• UDI-Public: 00814548018355
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173614
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: RBY4C0620
• Device Lot Number: F00016324
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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: 76 YR
• Patient Sex: Female