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

Catalog Number	RBY4C0835
Medical Device Problem Codes	Positioning Failure (1158); Failure to Fold (1255); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2017
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.This report is associated with mfr report number: 3005168196-2017-01822.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to implant two ruby coils in the target vessel, the physician noticed that the coils were not taking their intended shape; therefore, they were removed.The procedure was completed using a non-penumbra coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note the device is no longer available for return as mentioned in the initial mdr; therefore, the mdr was updated accordingly.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-01822.The hospital discarded the device.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6969064
• Report Number: 3005168196-2017-01821
• Device Sequence Number: 11130908
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• 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,Followup
• Report Date (Section B): 09/25/2017

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: 12/01/2023
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F66763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1