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

Catalog Number	RBY2C0410
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pusher assembly was fractured, the pull wire was retracted out of the pusher assembly distal tip, and the embolization coil was detached.If the ruby coil is advanced against resistance, damage such as a kink may occur.Subsequently, if the device is retracted against resistance, the kink may worsen to a fracture.This damage likely caused the embolization coil to unintentionally detach during the procedure.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed bends and kinks along the pusher assembly and offset coil winds on the detached embolization coil.This damage is likely incidental to the complaint and may have occurred during packaging of the device for return to penumbra.Penumbra devices 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a branch of the superior mesenteric artery (sma) using a ruby coil, a non-penumbra microcatheter, and a guidewire.During the procedure, while advancing the ruby coil through the microcatheter, the ruby coil became stuck.The physician decided to retract the ruby coil and noticed that the ruby coil unintentionally detached within microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed.The ruby coil was flushed out of the microcatheter using a 3cc syringe on the back table and the microcatheter was flushed.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.

• 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: 21877961
• Report Number: 3005168196-2025-00127
• Device Sequence Number: 7864838
• Product Code: HCG
• UDI-Device Identifier: 00814548018577
• UDI-Public: 00814548018577
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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: RBY2C0410
• Device Lot Number: F00012723
• 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: 03/25/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2024
• 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: 89 YR
• Patient Sex: Male