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

Catalog Number	RBYXL4070
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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak of the abdominal aortic aneurysm (aaa) graft using a ruby xl, a non-penumbra catheter, and a radio frequency guidewire (rf guidewire).During the procedure, the rf guidewire was used multiple times prior to the advancement of the ruby xl.While advancing the ruby xl through the catheter, the physician experienced resistance, and the ruby xl became stuck.Upon attempting to retract the ruby xl, the embolization coil unintentionally detached within the catheter.The catheter containing the detached ruby xl was removed.It was reported that the catheter was damaged with the usage of the rf guidewire.The procedure was completed using another ruby xl, two packing coil xls, and a new non-penumbra catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned, and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned ruby xl confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was intact, and the pet bump was advanced distal to the distal detachment tip (ddt).If the ruby xl is manipulated against resistance, the pusher assembly may elongate beyond the reach of the distal tip of the pull wire, causing the embolization coil to detach.The kinks on the non-penumbra catheter may have caused resistance during the procedure.Further evaluation revealed a kink and offset coil winds.This damage is 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.

• Brand Name: RUBY XL
• Common Device Name: 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: 23069395
• Report Number: 3005168196-2025-00294
• Device Sequence Number: 9662950
• Product Code: KRD
• UDI-Device Identifier: 00810169721650
• UDI-Public: 00810169721650
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K250079
• 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): 09/26/2025

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: RBYXL4070
• Device Lot Number: F00016522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: 70 YR
• Patient Sex: Male