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

Catalog Number	RBYLP0430
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being updated on this follow-up mfr report: 1.Section d.Box 6a.If implanted, give date.2.Section d.Box 8.Was this device serviced by a third party.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal mammary vessel using ruby coil lps and a non-penumbra microcatheter.During the procedure, the physician advanced a 3mm x 15cm ruby coil lp into the target vessel.However, the ruby coil lp would not take its intended shape.Therefore, the ruby coil lp was removed.The physician advanced a second ruby coil lp (2mm x 10 cm) to the target vessel.However, the same issue was experienced.Therefore, the second ruby coil lp was removed.The physician placed a new ruby coil lp (4mm x 30cm) in the target vessel.While opening another coil, the physician noticed under fluoroscopy that the ruby coil lp had migrated distally from one of the branches of the bifurcation.The physician indicated the ruby coil lp was in a safe location.A gel foam was used to fill the remaining space in the target site covering the ruby coil lp.The procedure was considered completed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 21663461
• Report Number: 3005168196-2025-00089
• Device Sequence Number: 7662540
• Product Code: HCG
• UDI-Device Identifier: 00815948026056
• UDI-Public: 00815948026056
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K230284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: RBYLP0430
• Device Lot Number: F00011069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: Unknown