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

Catalog Number	RBYLP0102
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured at its proximal end, and the pet lock was not present.This damage likely occurred during the reported detachment attempt using hemostats.Evaluation also revealed that the pull wire was retracted from its initial position on the distal tip of the pusher assembly.If the pull wire is retracted from its initial position, the embolization coil will detach from the pusher assembly.Further evaluation revealed kinks along the length of the pusher assembly and 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 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in left external using ruby coil lps, a packing coil lp, a lp detachment handle (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully placed two ruby coil lps and one packing coil lp in the target vessel.The physician advanced the next ruby coil lp using the microcatheter into the target vessel and attempted to detach the coil twice using the handle; however, the ruby coil lp failed to detach.Hemostats were used to bend the ruby coil lp pusher assembly, but the embolization coil still did not detach.While retracting the ruby coil lp, the embolization coil detached within the microcatheter.The microcatheter containing the detached embolization coil was removed from the patient and flushed out of the microcatheter on the back table.It was reported that the pusher assembly was fractured.The procedure was completed at this point.There was no report of an adverse effect to the patient.

• 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: 23356395
• Report Number: 3005168196-2025-00338
• Device Sequence Number: 21048062
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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): 10/22/2025

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: RBYLP0102
• Device Lot Number: F00007152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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 Age: 84 YR
• Patient Sex: Female