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

Model Number	RBY4C0630-A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Coil did not deploy when it was triggered.

• Brand Name: RUBY COIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7850480
• Report Number: 7850480
• Device Sequence Number: 13768949
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: (01)00814548013190(17)251212(10)F81022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018
• Report Date (Section F): 08/20/2018

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: RBY4C0630-A
• Device Lot Number: F81022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82
• Date Report Sent to FDA: 08/20/2018