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

Catalog Number	RBY2C2457
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil was inside the lantern and the pusher assembly was fractured on either side of the rhv.During investigation, the pusher assembly was removed from the lantern.Conclusions: evaluation of the first ruby coil revealed a kinked pusher assembly and a damaged embolization coil.This damage typically occurs as a result of forcefully advancing the device against resistance.Further evaluation revealed the pull wire protruding distally from the distal detachment tip (ddt).This is likely a result of forcefully advancing the device against resistance and may have damage the lantern liner during repeated manipulation.A portion of the liner was flushed out of the returned lantern during evaluation.Evaluation of the second ruby coil revealed a kinked and fractured pusher assembly.This damage typically occurs as a result of forcefully advancing the device against resistance.If the pusher assembly becomes fractured, it will likely allow the pull wire to retract from the ddt allowing the embolization coil to detach.Evaluation of the returned lantern revealed a kink on the distal length of the device.If the lantern is mishandled during preparation or forcefully manipulated within difficulty patient anatomy, the device may become kinked.One of the returned embolization coils was returned stuck within the lantern kink.This kink likely contributed to the resistance experienced when advancing the two subject ruby coils during the procedure.Penumbra coils and catheters are inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2019-00059; 3005168196-2019-00061.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed a ruby coil in the target vessel.While advancing a new ruby coil, it unintentionally detached within the lantern.Therefore, the physician used a 60cc syringe to aspirate the detached ruby coil out of the lantern.The physician then advanced a new ruby coil, however felt resistance after advancing it half way through the lantern.Therefore, the physician removed the ruby coil and the lantern; however, the lantern was noted to be kinked mid shaft.The procedure was therefore completed using new ruby coils and a new 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: 8241520
• Report Number: 3005168196-2019-00060
• Device Sequence Number: 16675650
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 12/13/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 09/10/2025
• Device Catalogue Number: RBY2C2457
• Device Lot Number: C08042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/11/2019
• 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
• Date Report Sent to FDA: 01/01/2005