MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	RBY2C0320-B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Coils detached on their own.No harm/injury to patient.

• Brand Name: RUBY COIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 13357734
• Report Number: 13357734
• Device Sequence Number: 1648021
• Product Code: KRD
• UDI-Device Identifier: 00814548018560
• UDI-Public: (01)00814548018560(17)281020(10)F101390
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2022
• Report Date (Section F): 01/21/2022

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: RBY2C0320-B
• Device Catalogue Number: RBY2C0320
• Device Lot Number: F101390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 01/21/2022