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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
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.Please note that the manufacturer could not determine which lot numbers corresponded to the two ruby coils that unintentionally detached within the lantern and which lot number corresponded to the ruby coil that would not advance within its introducer sheath.Therefore, the same evaluation codes will be provided on this report and the associated report listed below except for mfr# 3005168196-2018-01160.This report is associated with mfr report numbers: 3005168196-2018-01157, 3005168196-2018-01159, 3005168196-2018-01160.The hospital discarded the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician felt resistance while advancing a ruby coil through the lantern and, consequently, the ruby coil unintentionally detached within the lantern.The physician therefore removed the rotating hemostatic valve (rhv) to pull out the ruby coil from the lantern.The physician then successfully placed another ruby coil.The physician then felt resistance while advancing another ruby coil within the lantern and, consequently the ruby coil unintentionally detached within the lantern.The physician again was able to remove the ruby coil by hand after removing the rhv.The physician then switched to a new lantern and successfully placed multiple ruby coils.However, the physician then felt resistance while advancing another ruby coil within its introducer sheath and into the lantern and thought that the pusher assembly was damaged, though no specific damage was noticed.The physician therefore removed the ruby coil.The procedure was completed using additional ruby coils, pod coils, and the same lantern.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: 7596670
• Report Number: 3005168196-2018-01158
• Device Sequence Number: 16444340
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 05/14/2018

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: 07/30/2025
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F78447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR