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

Catalog Number	RBY4C0201-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pet lock on the proximal end of the ruby coil pusher assembly was intact.The pusher assembly was bent approximately 141.5 cm from the proximal end.The embolization coil was intact with the pusher assembly.The maximum outer diameter (od) of the ruby coil was measured to be within specification.Evaluation of the returned device revealed a slight bend on the pusher assembly.This damage may have occurred due to forceful manipulation of the ruby coil during use.Further evaluation revealed that the ruby coil od was within specification and was able to successfully advance through a demonstration px slim without difficulty.Therefore, the root cause of the resistance mentioned in the complaint could not be determined.The ruby coil introducer sheath and the non-penumbra microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.While advancing the second ruby coil through a non-penumbra microcatheter, the physician felt resistance and was unable to advance the ruby coil past the tip of a non-penumbra microcatheter.Therefore, the ruby coil was removed from the patient.The procedure was completed using the same microcatheter and another ruby coil.The physician flushed frequently and did not use a rotating hemostasis valve.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Report source.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5970313
• Report Number: 3005168196-2016-01361
• Device Sequence Number: 10991036
• Product Code: HCG
• UDI-Device Identifier: 00814548013114
• UDI-Public: 00814548013114
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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): 08/25/2016
• 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: Physician
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: RBY4C0201-A
• Device Lot Number: F65044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005