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

Catalog Number	RBY2C0840
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device code that also applies to this complaint: (b)(4).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 ovarian vein using ruby coils, and a non-penumbra microcatheter.During the procedure, the physician successfully placed one ruby coil in the target vessel.While advancing the next ruby coil through the microcatheter, the physician experienced resistance.The physician continued to advance the ruby coil and the pusher assembly became kinked and fractured.Subsequently, the ruby coil unintentionally detached in the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed from the patient.The procedure was completed using a new non-penumbra microcatheter and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the pusher assembly was kinked and fractured, and the embolization coil was detached from the pusher assembly.If the ruby coil is advanced against resistance, damage such as kinks and a subsequent fracture may occur.If the pusher assembly fractures, and the pull wire is retracted out of the pusher assembly distal tip, the embolization coil will detach.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed ovalizations on the introducer sheath, and the embolization coil was unraveled due to the proximal constraint sphere not being present on the embolization coil.This damage was incidental to the complaint and the root cause could not be determined.Penumbra coils 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, CA 94502 ; 5107483200
• MDR Report Key: 21439936
• Report Number: 3005168196-2025-00054
• Device Sequence Number: 14603594
• Product Code: HCG
• UDI-Device Identifier: 00814548018867
• UDI-Public: 00814548018867
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/04/2025

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: RBY2C0840
• Device Lot Number: F113623
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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: 47 YR
• Patient Sex: Female