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

Catalog Number	RBY2C1460
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2019
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: 3005168196-2019-01113.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and pod14s.During the procedure, the pusher assembly of a ruby coil became kinked while being removed from the packaging hoop.The damage to the ruby coil occurred prior to use and, therefore, it was not used in the procedure.The physician then felt resistance while advancing the pod14 into the lantern delivery microcatheter (lantern) and, consequently, the pod14 unintentionally detached.The physician was able to pull out the pod14, and the procedure was then completed using a pod12 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: 8674899
• Report Number: 3005168196-2019-01112
• Device Sequence Number: 2220700
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 00814548019116
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 05/09/2019
• 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: 06/26/2026
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F84354
• 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: 05/09/2019
• Initial Report FDA Received Date: 06/06/2019
• 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