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

Model 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	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the prostate artery using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil lp into the microcatheter and reported that the coil became stuck near the distal end and unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil lp was removed from the patient, and the coil was flushed out on the back table.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was detached from the pusher assembly and was not returned for evaluation.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted from the distal end of the pusher assembly.This typically occurs during a successful detachment attempt.If the pet lock is inadvertently separated during manipulation of the device, the pull wire may retract out of the pusher assembly distal tip causing the embolization coil to detach from its pusher assembly.Based on the reported complaint, the root cause of the pet lock separating could not be determined.Further evaluation revealed bends and kinks on the pusher assembly this damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for both lots were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Please note that two lot numbers were provided: f00014510 and c00015512: it is unknown which lot number is associated with the reported event.1.Lot #: f00014510, manufacture date: 2024-11-11, expiration date: 2029-11-10.2.Lot #: c00015512, manufacture date: 2021-01-27, expiration date: 2026-01-26.

• 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 farris ; one penumbra place; alameda, CA 94502
• MDR Report Key: 21963978
• Report Number: 3005168196-2025-00154
• Device Sequence Number: 9274424
• Product Code: HCG
• UDI-Device Identifier: 00815948025967
• UDI-Public: 00815948025967
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230284
• 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): 05/05/2025

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 Model Number: RBYLP0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male