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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the proximal segment of the splenic artery using a ruby coil.During the procedure, the physician placed a non-penumbra diagnostic catheter, then advanced a ruby coil through a lantern delivery microcatheter (lantern).While attempting to get the ruby coil to seat in the target vessel, the physician noticed that the coil wasn't coming back with the pusher assembly.At this point, approximately 10 cm of the ruby coil was outside of the distal tip of the lantern.Therefore, the physician removed the coil's pusher assembly, attached a syringe to the back of the lantern and pulled negative pressure back in an attempt to try to keep the ruby coil in the lantern when removing it.The lantern was then removed with the ruby coil now residing inside of the diagnostic catheter.There was approximately 12 cm of coil outside of the tip the diagnostic catheter and it was determined that the safest option was to push the detached coil out of the diagnostic catheter where it migrated into the distal splenic artery.The ruby coil was left in the vessel after thoughtful consideration to snare it.The procedure was completed using other coils.It should be noted that there was no noted damage or issue with the lantern.Additionally, there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device was implanted into the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7290377
• Report Number: 3005168196-2018-00394
• Device Sequence Number: 1483637
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: Physician
• Device Expiration Date: 11/05/2025
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F80391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1