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

Catalog Number	RBY4C0860
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
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 using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, the ruby coil stretched and unintentionally detached within the lantern.Therefore, the detached ruby coil was removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 12/20/2024: 1.Section a.Box 3.Sex 2.Section b.Box 5.Describe event or problem.Additional information was added to: 1.Section h.Box 6.Component code 1 and component code 2 2.Section h.Box 6.Health effect impact code 1.Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the sr component was fractured.If the ruby coil is retracted against resistance, damage such as a sr component fracture may occur.This likely contributed to the coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the reported 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acoa) and aortic sac to treat a type ii endoleak using a ruby coil, a lantern delivery microcatheter (lantern) and non-penumbra guide catheter.During the procedure, while advancing the ruby coil out of the lantern, the lantern slipped back into the guide catheter.Without realizing that the lantern had slipped back into the guide catheter, the physician advanced most of the ruby coil out of the lantern and the ruby coil formed within the guide catheter.The physician then attempted to retract the ruby coil; however, upon retraction the ruby coil unintentionally detached, with part of the coil within the lantern.Therefore, the physician removed the guide catheter containing the lantern and detached ruby coil.Upon removal of the ruby coil from the guide catheter outside the patient, the physician noticed that the ruby coil was stretched.The procedure was completed using additional ruby coils and a non-penumbra 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 Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20606765
• Report Number: 3005168196-2024-00374
• Device Sequence Number: 12627185
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025
• Report Date (Section F): 01/01/2005

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: RBY4C0860
• Device Lot Number: F00009838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: Female
• Date Report Sent to FDA: 01/01/2005