MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	RBY2C1857-A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A ruby coil failed to deploy.There were no complications.Notes from the procedure: following transjugular intrahepatic portosystemic (tips) shunt creation, a kumpe catheter was advanced into the splenic vein and a splenic venogram performed.This demonstrated two large gastroesophageal varices.Using a 5 french c2 catheter, the first of these varices was selected.Under fluoroscopic guidance, a nest of coils was deployed to occlude this varix.The secondary was then selected, and again under fluoroscopic guidance a nest of coils was deployed to occlude this varix.Following embolization of these two varices, the catheter was positioned within the splenic vein and a post embolization venogram performed demonstrating no further significant varices.The catheter was then removed.Patient tolerated the procedure well with no immediate complications.

• Brand Name: RUBY COIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7905067
• Report Number: 7905067
• Device Sequence Number: 1787486
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: (01)00814548013060(17)260313(10)F82340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2018
• Report Date (Section F): 09/21/2018

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: RBY2C1857-A
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F82340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68
• Date Report Sent to FDA: 09/21/2018