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

Catalog Number	RBY2C0410
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the supraduodenal artery using ruby coils.During the procedure, the physician successfully placed two ruby coils into the target vessel using a lantern delivery microcatheter (lantern).After advancing the third ruby coil into the target vessel, the physician decided to reposition the ruby coil within the vessel and reported feeling resistance while advancing.The physician then advanced the non-penumbra diagnostic catheter further over the lantern to gain additional support, and retracted the ruby coil back into the lantern, in preparation to detach the ruby coil.However, it was reported that while retracting the ruby coil back into the lantern, the ruby coil unintentionally detached.The physician was able to push the remaining 1 cm of the ruby coil out of the lantern into the vessel using the coil's pusher assembly.The lantern was then flushed, and the procedure was completed using the same lantern and additional ruby coils.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: 8357426
• Report Number: 3005168196-2019-00321
• Device Sequence Number: 10808820
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019
• 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: 04/19/2025
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F75790
• Was Device Available for Evaluation?: No
• 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: 01/23/2019
• Initial Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005