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

Catalog Number	RBY2C0620-A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 49.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device confirmed the pusher assembly was kinked.This damage likely occurred due to forceful manipulation of the ruby coil at an angle during removal from the packaging or preparation for use.Ruby coils are 100% functionally evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a coil embolization procedure, the ruby coil pusher assembly became kinked.The pusher assembly became kinked prior to use and therefore, the ruby coil was not used for the procedure.The procedure was successfully completed using a new ruby coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5663235
• Report Number: 3005168196-2016-00678
• Device Sequence Number: 18834487
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/18/2016

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: 11/30/2022
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F61486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2016
• Initial Report FDA Received Date: 05/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1