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

Catalog Number	RBY2C3260
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using ruby coils.During the procedure, the physician successfully placed a coil in the target vessel.Next, a ruby coil was advanced, then retracted in order to be repositioned.Upon retraction, the ruby coil unintentionally detached within the lantern delivery microcatheter (lantern).The lantern and ruby coil were therefore removed from the patient, and the ruby coil was removed from the lantern.The same lantern was then re-advanced into the target vessel and the procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8363371
• Report Number: 3005168196-2019-00334
• Device Sequence Number: 1959927
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019
• 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 Catalogue Number: RBY2C3260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Date Report Sent to FDA: 01/01/2005