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

Model Number	RBY4C0415-B
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left gastric artery using ruby coils and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician encountered resistance while advancing the ruby coil around a curve in the vasculature but was able to continue advancing the coil smoothly.When the ruby coil reached the target location, the physician pulled back on the pusher wire to pack the coil more tightly.However, the ruby coil was not retracting as expected and the physician noticed that the ruby coil had become unintentionally detached.It was reported that the ruby coil was partially in the microcatheter and partially in the patient's vessel when it detached.Therefore, the microcatheter containing the ruby coil was removed, and the coil was flushed out on the back table.It was also reported that the ruby coil pusher wire was kinked; however, it is unknown when it became kinked.The procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the ddt was fractured off the distal tip of the pusher assembly.If the ruby coil is manipulated against resistance during use, damage such as the ddt fracture may occur.This damage likely contributed to the embolization coil detaching from its pusher assembly.The ddt is the component that keep the embolization coil intact with its pusher assembly.Further evaluation revealed pusher assembly kinks and offset coil winds on the embolization coil.This damage was incidental to the reported complaint.The pusher assembly kink likely occurred during the procedure as mentioned in the complaint.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.

• 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: 14046544
• Report Number: 3005168196-2022-00163
• Device Sequence Number: 4775620
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 00814548018348
• 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): 05/04/2022
• 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 Model Number: RBY4C0415-B
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F108054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• 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: 03/19/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• 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: 63 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005