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

Catalog Number	RBY2C3260
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an aortic aneurysm sack using ruby coils.During the procedure, the physician deployed and detached a ruby coil in the target vessel.While attempting to reposition a ruby coil through a lantern delivery microcatheter (lantern), the physician noticed that the ruby coil did not retract with its pusher assembly, indicating that the ruby coil had unintentionally detached.Since most of the detached ruby coil was in the lantern, the physician attempted to flush out the detached ruby coil from the lantern; however, it was unsuccessful.The physician then used a wire and pushed the detached ruby coil; however, the lantern became repositioned in the inferior mesenteric artery (ima) and the detached ruby coil was deployed in the ima which eliminated access to the aortic aneurysm sack.The physician did not make an attempt to remove the detached coil since the ima was going to be embolized as well.The procedure was completed at that point.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: 8044704
• Report Number: 3005168196-2018-02199
• Device Sequence Number: 13778577
• Product Code: HCG
• UDI-Device Identifier: 00814548019321
• UDI-Public: 00814548019321
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018
• 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: 06/16/2026
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F84098
• 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: 10/08/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005