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

Catalog Number	RBY2C1857
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the proximal constraint sphere was present on the embolization coil indicating the coil was intact.This type of damage typically occurs if the ruby coil is retracted against resistance during use, the pusher assembly may elongate allowing the embolization coil to detach.The pusher assembly was not returned for evaluation.Therefore, the root cause could not be determined.Further evaluation revealed offset coil winds on the embolization coil.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 gastroduodenal artery (gda) aneurysm using a ruby coil, a ruby xl, a non-penumbra catheter (5f), and a lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician was unable to advance a ruby xl through the 5f non-penumbra catheter, and the ruby xl was removed.The physician then inserted the lantern through the non-penumbra catheter and placed three ruby coils in the target location using the lantern.While advancing another ruby coil into the target location, the lantern had kicked out of the vessel and the ruby coil unintentionally detached.It was reported that the detached ruby coil migrated from the gda to the hepatic artery.The physician was able to remove the detached ruby coil using a snare device after multiple attempts.The physician determined that the aneurysm was occluded enough and ended the procedure at this point.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: 23334167
• Report Number: 3005168196-2025-00333
• Device Sequence Number: 15930234
• Product Code: HCG
• UDI-Device Identifier: 00814548019260
• UDI-Public: 00814548019260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/19/2025

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: RBY2C1857
• Device Lot Number: F00015524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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: 65 YR
• Patient Sex: Male