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

Catalog Number	RBY2C0530
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	07/21/2025
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 in the internal iliac artery using a ruby coil, a lantern delivery microcatheter (lantern), a non-penumbra diagnostic catheter, and a non-penumbra sheath.During the procedure, the physician was experiencing resistance advancing the distal end of the lantern through the diagnostic catheter.The physician was then advancing a ruby coil through the lantern, but the ruby coil became stuck at the distal end of the lantern.While attempting to retract the ruby coil, the physician experienced resistance, and the ruby coil had unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed and the physician noticed the lantern was kinked.The procedure was completed using new ruby coils, new pod packing coils (packing coil), a new lantern, the same diagnostic catheter, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the second returned ruby coil confirmed that the embolization coil was detached and stuck inside the returned lantern.Evaluation revealed that the pusher assembly was kinked and fractured, and the pull wire was retracted out of the distal fractured segment.If the ruby coil is advanced against resistance, damage such as kinks may occur.Subsequently, retraction of a kinked pusher assembly may worsen to a fracture, resulting in the embolization coil detachment.Further evaluation revealed bends along the pusher assembly and offset coil winds on the embolization coil.This damage was incidental to the complaint and may have occurred after removal of the device from the procedure or during packaging for return to penumbra.Penumbra devices are 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 94502 ; 5107483200
• MDR Report Key: 22811791
• Report Number: 3005168196-2025-00262
• Device Sequence Number: 7798774
• Product Code: HCG
• UDI-Device Identifier: 00814548018645
• UDI-Public: 00814548018645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/12/2025

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: RBY2C0530
• Device Lot Number: F109182
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 83 YR
• Patient Sex: Female