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

Catalog Number	RBYLP0204
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was separated, and the pull wire was retracted from its original position on the distal tip of the pusher assembly.If this occurs, the embolization coil will detach from its pusher assembly.The detached embolization coil was not returned for evaluation and the returned condition of the device indicates a successful coil detachment attempt.Therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed kinks on the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for returned to penumbra.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 the fifth to sixth branch of the right hepatic artery using a ruby coil lp, a lp system detachment handle (lp handle), and a non-penumbra microcatheter.During the procedure, the physician advanced the ruby coil lp into the target location using the microcatheter and attempted to detach the coil using the lp handle; however, the ruby coil lp did not detach.The physician then attempted to manually detach the ruby coil lp, without success.Therefore, the physician decided to remove the ruby coil lp.While retracting the ruby coil lp from the microcatheter, the ruby coil lp became stuck and subsequently detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil lp was removed and the coil was flushed out on the back table.The procedure was completed using non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 1 mfr report: 1.Section d.Box 4.Unique identifier.H3 other text: placeholder.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 19639528
• Report Number: 3005168196-2024-00234
• Device Sequence Number: 7065154
• Product Code: HCG
• UDI-Device Identifier: 00815948021754
• UDI-Public: 00815948021754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024
• Report Date (Section F): 01/01/2005

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: RBYLP0204
• Device Lot Number: F111520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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: 73 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005