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

Model Number	RBY4C0315-B
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2021-02526.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils, a ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a ruby coil to the target vessel and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the physician manually detached the ruby coil.The physician then advanced another ruby coil to the target vessel and successfully detached it using the handle.However, after the detachment, the pusher assembly of the ruby coil became stuck in the handle.Therefore, the handle was not used for the remainder of the procedure.It was reported that the handle was unable to fully cover the pusher assemblies of the ruby coils and that the physician experienced resistance while advancing the pusher assemblies of the ruby coils into the handle.The procedure was completed using a new handle and additional ruby coils.There was no report of an adverse effect to the patient.

• 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: 12778947
• Report Number: 3005168196-2021-02527
• Device Sequence Number: 17579791
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021
• 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: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F108070
• Was Device Available for Evaluation?: No
• 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: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005