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

Catalog Number	RBY2C0410
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	01/15/2025
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 gastroduodenal artery (gda) using ruby coils, pod packing coils (packing coil), and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil through the microcatheter; the physician met resistance.Subsequently, the ruby coil unintentionally detached within the microcatheter.Therefore, the physician successfully flushed the detached ruby coil into the target vessel.Next, after removing the ruby coil's pusher assembly, the physician began advancing a packing coil through the microcatheter.However; resistance was felt and the coil stopped advancing at the proximal location of the microcatheter.Therefore, the physician removed the packing coil.The microcatheter was then removed.Upon inspection, the physician noticed the ruby coil's pusher assembly had fractured and half remained within the microcatheter.The procedure was completed with 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 confirmed that the embolization coil was unintentionally detached.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pusher assembly was fractured, and the pull wire was retracted out at the fractured location.If the ruby coil is advanced against resistance, damage such as a kink and subsequent fracture on the pusher assembly may occur.The fracture on the pusher assembly likely caused the pull wire to retract and the embolization coil to detach from the pusher assembly.Based on the reported complaint, the root cause of resistance during procedure could not be determined.The detached embolization coil was implanted in the target vessel; therefore, it was not returned for evaluation.Further evaluation revealed additional fractures, a kink on the proximal end of pusher assembly and bends throughout the pusher assembly.This damage was likely incidental to the reported complaint and may have occurred during packaging of the device 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: 21337152
• Report Number: 3005168196-2025-00034
• Device Sequence Number: 3758553
• Product Code: HCG
• UDI-Device Identifier: 00814548018577
• UDI-Public: 00814548018577
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 03/31/2025

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: F00007299
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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