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

Catalog Number	RBY2C0840
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left ventricular outflow tract (lvot) aneurysm using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil as the first coil into the aneurysm; however, the coil would not anchor.Therefore, the physician decided to retract the ruby coil to reposition the lantern.Subsequently, upon attempting to retract the ruby coil, the physician noticed the coil would not pull back and, the ruby coil had unintentionally detached inside the lantern.The physician then used a syringe to pull negative pressure on the lantern and the lantern containing the detached ruby coil was removed together as a unit.It was reported that more than half of the detached ruby coil was still inside the lantern and upon flushing the lantern on the back table, the physician noticed the ruby coil had unraveled and was not intact with the remainder of the coil being stuck inside the lantern.The procedure was completed using a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the sr component was fractured.If the ruby coil is retracted against resistance, damage such as an sr component may fracture.This damage likely contributed to the embolization coil detaching during the procedure.Based on the reported complaint, the root cause of resistance could not be determined.Penumbra coils are 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.

• 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: 15709858
• Report Number: 3005168196-2022-00509
• Device Sequence Number: 6621728
• Product Code: HCG
• UDI-Device Identifier: 00814548018867
• UDI-Public: 814548018867
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/28/2022
• 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: RBY2C0840
• Device Lot Number: F00001527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• 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: 10/06/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005