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

Catalog Number	RBY4C0202
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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 right pulmonary artery using ruby coils and a non-penumbra microcatheter.During the procedure, the physician advanced the ruby coil into the vessel, but the coil did not form as desired in the vessel.Therefore, the ruby coil was re-sheathed and removed.After regaining access to the target location, the physician began advancing the same ruby coil into the vessel, however, it was not forming correctly.The physician then decided to remove the ruby coil.While retracting the ruby coil, the coil unintentionally detached inside the microcatheter.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.The procedure was completed with additional ruby coils.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 right pulmonary artery using a ruby coil, non-penumbra microcatheters, and a non-penumbra angiographic catheter.During the procedure, the physician advanced the ruby coil into the vessel, but the coil did not form as desired in the vessel.Therefore, the ruby coil was re-sheathed and removed.The physician began advancing the same ruby coil into the vessel, however, the coil was not forming correctly.The physician then decided to remove the ruby coil.While retracting the ruby coil, the coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the coil was flushed out.It was reported that in the process of removing the microcatheter and the detached ruby coil, the physician lost access, and the angiographic catheter was pulled back into the main pulmonary artery.The physician inserted the guidewire into the angiographic catheter and was able to regain access feeding the pseudoaneurysm.The procedure was completed using a new microcatheter and an embolic agent.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on on 07/07/2025: 1.Section b.Box 5.Describe event or problem.

• 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: 22416976
• Report Number: 3005168196-2025-00229
• Device Sequence Number: 6978900
• Product Code: HCG
• UDI-Device Identifier: 00814548018263
• UDI-Public: 00814548018263
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: RBY4C0202
• Device Lot Number: F00015155
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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: 11 MO
• Patient Sex: Female