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

Catalog Number	RBY4C0860
Medical Device Problem Codes	Unraveled Material (1664); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5090583.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using ruby coils.During advancement to the ima via the superior mesenteric artery (sma), a ruby coil detached from its pusher assembly and unraveled.No additional information is currently available.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9432292
• Report Number: 3005168196-2019-02240
• Device Sequence Number: 2238003
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2019
• 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 Catalogue Number: RBY4C0860
• 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: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• 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