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

Catalog Number	RBYXL4070
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery via contralateral approach using a ruby xl, a non-penumbra catheter, and a non-penumbra sheath.During the procedure, while attempting to advance the ruby xl out of the distal end of the catheter, the ruby xl would not advance out of the catheter.The physician attempted to advance the ruby xl out of the distal end of the catheter a few times without success.The physician decided to retract the ruby xl.While retracting the ruby xl, the embolization coil unintentionally detached within the catheter.The catheter containing the detached ruby xl was removed from the patient and the coil was flushed out of the catheter on the back table.The procedure was completed using additional ruby xl coils, the same angiographic catheter, and the same sheath.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.

• Brand Name: RUBY COIL 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: 22789748
• Report Number: 3005168196-2025-00264
• Device Sequence Number: 9823081
• Product Code: KRD
• UDI-Device Identifier: 00810169721650
• UDI-Public: 00810169721650
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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 Expiration Date: 05/19/2026
• Device Catalogue Number: RBYXL4070
• Device Lot Number: C00018435
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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 Sex: Unknown