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

Catalog Number	RBY2C3660
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	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned, and the investigation results are pending.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 in the coronary artery using ruby coils and a lantern delivery microcatheter (lantern).It should be noted that the patient¿s anatomy was moderately tortuous and moderately calcified.During the procedure, the physician successfully implanted three ruby coils in the target location using the lantern.While advancing another ruby coil through the lantern, the physician experienced resistance at the mid-shaft of the lantern.While attempting to retract and re-advance the ruby coil within the lantern, the ruby coil unintentionally detached.Therefore, the lantern containing the detached ruby coil was removed from the patient, and the ruby coil was then flushed out of the lantern.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
Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted out of the distal fracture.If the ruby coil is advanced against resistance, damage such as kink may occur.Subsequently, retraction of a kinked pusher assembly may worsen to a fracture, resulting in the embolization coil detachment.The reported patient¿s moderately tortuous and calcified anatomy may have caused resistance during the procedure.Further evaluation revealed a kink on the pusher assembly.This damage is incidental 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 farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 23687814
• Report Number: 3005168196-2025-00381
• Device Sequence Number: 9583889
• Product Code: HCG
• UDI-Device Identifier: 00814548019420
• UDI-Public: 00814548019420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: RBY2C3660
• Device Lot Number: F00014948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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 Sex: Unknown