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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00284.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superficial femoral artery (sfa) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, a ruby coil was advanced into the target vessel, however, the coil was not forming to the physician's satisfaction; therefore, the ruby coil was removed.The physician then proceeded to place a new ruby coil with no issue.When advancing another ruby coil in the aneurysm, the physician was not able to get a good pack because the coil was too long.The physician then decided to remove the ruby coil; however, the position of the base catheter was very unstable and subsequently, the ruby coil unintentionally detached.The physician felt that the lantern was relatively stable, and injected approximately half of the coil in the sfa.The physician used a snare device to remove the remainder of the ruby coil in three passes.The physician then switched to a new base catheter and a new lantern and the procedure was successfully completed using additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that additional information provided on 20-march-2018 indicated that the device was not available for return; therefore, the report has been updated and corrected accordingly.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.The hospital disposed of the device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7247997
• Report Number: 3005168196-2018-00285
• Device Sequence Number: 13711165
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/11/2025
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F79486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR