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

Catalog Number	RBY2C2457
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
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.This report is associated with mfr report numbers: 3005168196-2018-01348, 3005168196-2018-01350.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing coil embolization to treat an abdominal aortic aneurysm endoleak (aaa endoleak) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician deployed two ruby coils in the target vessel and used a handle to detach the coils.The physician then advanced another ruby coil in the target vessel and used the handle to detach it; however, the ruby coil failed to detach completely.It was reported that the handle was not making the same clicking sound.Therefore, the physician opened a new handle and successfully detached the ruby coil.Next, the hospital technologist, bent and broke a ruby coil pusher assembly on the back table while removing the ruby coil out of the dispenser hoop.Therefore, the ruby coil was set aside and the procedure was completed using another ruby coil and the second handle.There was no report of an adverse effect to 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: 7665080
• Report Number: 3005168196-2018-01349
• Device Sequence Number: 11391794
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/11/2018

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: 03/13/2026
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F82368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR