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

Catalog Number	RBY2C2060
Medical Device Problem Codes	Positioning Failure (1158); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
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 left subclavian artery using ruby coils.During the procedure, the physician attempted to place a ruby coil, however, the coil would not hold its position due to the high flow of the vessel.Therefore, the ruby coil was removed.The physician then successfully placed a new ruby coil using a lantern delivery microcatheter (lantern).The physician then attempted to reuse the first ruby coil, however felt resistance advancing the ruby coil into the lantern.Therefore, the ruby coil was removed.A new ruby coil was then advanced into the target location; however, it would not safely hold its position due to the high flow in the vessel and, therefore, the coil was removed.The physician then did a contrast injection and decided to end the procedure because the existing embolization was sufficient.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: 8402107
• Report Number: 3005168196-2019-00429
• Device Sequence Number: 297722
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 02/06/2019
• 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: 05/14/2026
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F83472
• 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: 02/06/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005