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

Catalog Number	RBY4C1650
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2019
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 numbers: 3005168196-2019-00875; 3005168196-2019-00877; 3005168196-2019-00878; 3005168196-2019-00879.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the mesenteric artery and the aorta using pod5s and ruby coils.During the procedure, the fellow accidentally dropped a pod5 on the floor while removing it from the packaging hoop.The pod5 was dropped prior to use and, therefore, it was not used in the procedure.The procedure was then continued using a new pod5.The physician successfully placed multiple ruby coils using a lantern delivery microcatheter (lantern).The fellow then accidentally kinked a ruby coil (f83494) while removing it from the packaging hoop.The physician still attempted to advance the ruby coil through the lantern, however, was unable to.Therefore, the ruby coil was removed, and a new ruby coil was successfully placed.Throughout the remainder of the procedure, three more ruby coils were inadvertently kinked upon removal from their packaging hoops and, therefore, not used in the procedure.The procedure was completed using other 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: 8575028
• Report Number: 3005168196-2019-00876
• Device Sequence Number: 13962891
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 04/05/2019
• 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: 01/29/2026
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F81703
• 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: 04/05/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005