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

Model Number	RBY2C3660-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic vein using ruby coils and a non-penumbra microcatheter.During the procedure, the physician placed two ruby coils in the target location using the microcatheter.While advancing the next ruby coil through the middle of the microcatheter, the physician experienced resistance and decided to retract the ruby coil.However, upon retraction, it was noticed that the ruby coil had unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed and the ruby coil was flushed out on the back table.The procedure was completed using five ruby coils, non-penumbra coils, 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 was detached from the pusher assembly.Evaluation revealed that the pusher assembly ddt was fractured off and the embolization coil had offset coil winds at its proximal end.If the ruby coil is forcefully retracted against resistance during use, the ddt may become fractured off from the pusher assembly and the embolization coil may detach from the pusher assembly.The root cause of the resistance could not be determined.Further investigation revealed that the pusher assembly was kinked.This kink was likely incidental to the reported complaint and may have occurred during packaging for the device return.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: 12982161
• Report Number: 3005168196-2021-02780
• Device Sequence Number: 5352308
• Product Code: HCG
• UDI-Device Identifier: 00814548019420
• UDI-Public: 00814548019420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2021
• 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: RBY2C3660-B
• Device Catalogue Number: RBY2C3660
• Device Lot Number: F106858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 11/15/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• 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: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005