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

Model Number	RBY2C2060-A
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	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 splenic artery using ruby coils and a non-penumbra microcatheter.During the procedure, resistance was encountered when a ruby coil was advanced halfway into the microcatheter.Upon retraction, the physician noticed that the ruby coil had unintentionally detached in the microcatheter.Therefore, the physician flushed the detached ruby coil into the target vessel.Subsequently, the microcatheter was removed.The procedure was completed using another ruby coil and a new non-penumbra 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 pusher assembly was fractured and kinked near the fractured location.This damage likely occurred due to advancement against resistance during the procedure.If the pusher assembly fractures, the pull wire may retract from the pusher assembly distal detachment tip and the embolization coil may detach from the pusher assembly.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed additional kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Penumbra products are visually inspected during in-process 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: 12985631
• Report Number: 3005168196-2021-02781
• Device Sequence Number: 5743938
• Product Code: HCG
• UDI-Device Identifier: 00814548013077
• UDI-Public: 00814548013077
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022
• 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 Expiration Date: 05/31/2025
• Device Model Number: RBY2C2060-A
• Device Catalogue Number: RBY2C2060
• Device Lot Number: C25977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/16/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2017
• 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: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005