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

Catalog Number	RBY2C0930-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2016
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.This report is associated with mfr report number: 3005168196-2016-01059.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician deployed a ruby coil into the aneurysm using a lantern delivery microcatheter (lantern) but thought that the coil was undersized and decided to resheath the coil.While the physician was resheathing the ruby coil, it unintentionally detached within the lantern.The physician did not mention any resistance while attempting to resheath the coil.The entire lantern containing the detached coil was then removed.Next, a new lantern was opened and advanced into the patient.While attempting to advance a new ruby coil through the new lantern, the physician encountered resistance.Therefore, the ruby coil was removed intact and another manufacturer's coil was placed in the aneurysm.After placing the other manufacturer's coil, the physician successfully completed the procedure by deploying and detaching three new ruby coils using the second lantern.It should be noted that the physician did not have a continuous flush and was not using a rotating hemostasis valve (rhv).However, the physician did flush before and after every coil.Additionally, there was no alleged deficiency with the first lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).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 number: 3005168196-2016-01918.The hospital disposed of the device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5823540
• Report Number: 3005168196-2016-01060
• Device Sequence Number: 16324110
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2016

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: 02/28/2023
• Device Catalogue Number: RBY2C0930-A
• Device Lot Number: F62801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 12/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR