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

Catalog Number	RBY2C0725
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to advance a ruby coil more than halfway through a lantern delivery microcatheter (lantern); therefore the ruby coil was removed.The physician then flushed the lantern and successfully advanced a guidewire through the lantern.The physician then attempted to advance the ruby coil again; however met the same resistance and therefore, removed the ruby coil.The procedure was then completed using the same lantern and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6579903
• Report Number: 3005168196-2017-00773
• Device Sequence Number: 18860907
• Product Code: HCG
• UDI-Device Identifier: 00814548012957
• UDI-Public: 00814548012957
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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,Followup
• Report Date (Section B): 04/21/2017

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: Physician
• Device Expiration Date: 10/24/2023
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F66160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR