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

Model Number	RBY2C1240-A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We opened a ruby coil.The scrub nurse attempted to prep this for the surgeon and a piece of it broke.We were unable to fix this to be utilized.We ended up having to waste it.The actual coil was taken off of the sterile field.Per rn scrub, it separated when i was trying to get it out of the coil it comes in.Not sure if it was user error (as in i pushed it too much trying to get it out quickly) or if it was defective.By that point in the case it was very likely user error but since we weren't 100% sure we figured it was better safe than sorry and reported it.

• Brand Name: RUBY COIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; 6262 patterson pass rd; suite a; livermore CA 94550
• MDR Report Key: 11162996
• Report Number: 11162996
• Device Sequence Number: 19714481
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: (01)00814548013015(17)250618(10)F77797
• 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): 12/22/2020
• Report Date (Section F): 12/22/2020

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: RBY2C1240-A
• Device Lot Number: F77797
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 125
• Date Report Sent to FDA: 12/22/2020