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

Catalog Number	RBYLP0210
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a gi bleed using a ruby coil lp and a non-penumbra microcatheter.During the procedure, while advancing a ruby coil lp through the microcatheter, the ruby coil lp unintentionally detached within the microcatheter.The microcatheter containing the detached ruby coil lp was removed and the embolization coil was flushed out.The procedure was completed with a new ruby coil lp and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed a detached embolization coil.Evaluation revealed that the pusher assembly was fractured, the pull wire was retracted out of the distal fractured segment, and the embolization coil was detached and not returned for evaluation.If the ruby coil lp is manipulated against resistance, damage such as a kink and subsequent fracture to the pusher assembly may occur.Subsequently, if the fractured segments are separated, and the pull wire retracts out the pusher assembly distal tip, the embolization coil will detach.Based on the reported event, the root cause of resistance could not be determined.Further evaluation revealed a kink on the pull wire and kinks on the introducer sheath.This damage was incidental to the complaint and likely occurred during packaging for return to penumbra.There were no reported complaints regarding the demo packing coil lp, only the product pouch was slightly opened, and the device was not removed from its packaging; therefore, no evaluation was carried out on this device.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 LP
• 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: 23699968
• Report Number: 3005168196-2025-00383
• Device Sequence Number: 10192530
• Product Code: HCG
• UDI-Device Identifier: 00815948025998
• UDI-Public: 00815948025998
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• 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): 12/17/2025

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: RBYLP0210
• Device Lot Number: F00018154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 74 YR
• Patient Sex: Male