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

Model Number	RBY2C4060-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
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: 3005168196-2021-00515.
Event or Problem Description
The patient was undergoing a coil embolization procedure of an abernathy malformation shunt using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was tortuous.During the procedure, it was reported that the physician had difficulty advancing the lantern to the target location due to the tortuosity of the vessel.Subsequently, while advancing a ruby coil through the lantern, the physician experienced resistance and the ruby coil had unintentionally detached inside the lantern.Therefore, the lantern was removed containing the detached ruby coil.Upon further inspection, the physician noticed the distal tip of the lantern to be kinked.Therefore, the lantern was not used for the remainder of the procedure.The procedure was completed using a new lantern 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
• MDR Report Key: 11498963
• Report Number: 3005168196-2021-00514
• Device Sequence Number: 5257526
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021
• 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: RBY2C4060-B
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F101298
• Was Device Available for Evaluation?: No
• 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: 02/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005