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

Catalog Number	RBY2C0930
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-00366.The hospital disposed of the device.
Event or Problem Description
During preparation for a coil embolization procedure, the hospital staff noticed that a pod8 coil pusher assembly was broken upon removal from its dispenser hoop.Therefore, the pod8 coil was set aside.The physician then opened a ruby coil for the procedure; however, the coil was accidentally dropped on the floor.The broken pod8 coil pusher assembly and dropped ruby coil were found prior to use and therefore, the pod8 coil and ruby coil were not used in the procedure.The procedure was completed using additional ruby coils.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6407091
• Report Number: 3005168196-2017-00367
• Device Sequence Number: 10838566
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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: 11/27/2024
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F72287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1