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

Catalog Number	RBY2C0740
Medical Device Problem Codes	Detachment Of Device Component (1104); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
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: 3005168196-2018-01133, 3005168196-2018-01134, 3005168196-2018-01135, 3005168196-2018-01136, 3005168196-2018-01137.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a renal aneurysm using ruby coils and a ruby coil detachment handle (handle).During the procedure, while attempting to advance a ruby coil into a non-penumbra microcatheter, the physician noticed that the ruby coil was not advancing into the microcatheter; therefore, it was removed.It was reported that same issue occurred with four other ruby coils.Upon turning on the lights in the operating room, it was noticed that the embolization coils were on the ground.It was concluded that the five ruby coils, unknowingly at the time, had detached upon removal from the packaging hoops prior to the attempts made to advance them into the microcatheter.Next, the physician advanced a new ruby coil in the target vessel and used a handle to successfully detach it; however, it was reported that the ruby coil pusher assembly became stuck in the handle.The procedure was completed using a new handle, additional ruby coils and the same microcatheter.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: 7580717
• Report Number: 3005168196-2018-01132
• Device Sequence Number: 1523896
• Product Code: HCG
• UDI-Device Identifier: 00814548012964
• UDI-Public: 00814548012964
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/16/2018

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: 04/17/2024
• Device Catalogue Number: RBY2C0740
• Device Lot Number: F69000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1