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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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.This report is associated with mfr report number: 1.3005168196-2023-00102.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left interlobar arteries using a ruby coil, a pod packing coil (pod pc) and a lantern delivery microcatheter (lantern).During the procedure, while advancing the ruby coil through the lantern, the physician encountered resistance and the ruby coil unintentionally detached within the lantern.Therefore, the lantern was removed, and the ruby coil was flushed on the back table.The physician then placed and detached another ruby coil in the target vessel successfully using the same lantern.Next, the physician attempted to advance the pod pc; however, the physician encountered resistance and the pod pc unintentionally detached within the lantern.Therefore, the physician removed the lantern and flushed the pod pc out.The procedure was completed using another pod pc and the same lantern.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the sr component was fractured and the proximal constraint sphere from the embolization coil was present inside the distal tip of the pusher assembly.If the ruby coil is manipulated against resistance during use, damage such as sr component may fracture.This damage likely contributed to the ruby coils embolization coil detaching from the pusher assembly.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return.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.This report is associated with mfr report number: 1.3005168196-2023-00102.

• Brand Name: RUBY COIL
• 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: 16569516
• Report Number: 3005168196-2023-00101
• Device Sequence Number: 5895889
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 814548018324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (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): 04/19/2023
• 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: RBY4C0315
• Device Lot Number: F00003874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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
• Date Report Sent to FDA: 01/01/2005