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

Model Number	RBY2C3260-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the hospital staff noticed that the pusher assemblies of two ruby coils were bent upon removal from packaging on the back table.The damage to the ruby coils were found prior to use and therefore it was not used in the procedure.While inserting a ruby coil into the lantern, the hospital technician experienced resistance and subsequently, the ruby coil detached from its pusher assembly outside of the patient.Therefore, the technician pulled out the detached ruby coil using their fingers without having to remove the lantern.The procedure was completed using another ruby coil and the same lantern.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: 10997361
• Report Number: 3005168196-2020-02252
• Device Sequence Number: 19723327
• Product Code: HCG
• UDI-Device Identifier: 00814548019321
• UDI-Public: 00814548019321
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 11/16/2020
• 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: 06/16/2026
• Device Model Number: RBY2C3260-B
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F84098
• 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: 11/16/2020
• Initial Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005