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

Catalog Number	RBY2C0320
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2017
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, a ruby coil would not deploy.The manufacturer has requested additional information from the hospital; however, no additional information was provided.
Additional Manufacturer Narrative
Please note that the device was initially available for return; however, additional information obtained confirmed that the device was discarded by the hospital.The report was therefore 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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7010092
• Report Number: 3005168196-2017-01948
• Device Sequence Number: 10868528
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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 Catalogue Number: RBY2C0320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 69