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

Model Number	RBY4C0630-B
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00987.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed and detached five ruby coils into the target vessel using the handle.The physician then advanced another ruby coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the ruby coil failed to detach.Therefore, the ruby coil and handle were removed.The procedure was completed using a four ruby coils and a new handle.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed and detached five ruby coils into the target vessel using the handle.However, it was reported that the ruby coil pusher assembly became stuck in the handle.Therefore, the handle was removed.The procedure was completed using four ruby coils and a new handle.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: 3005168196-2020-00986.Results: the pull tube with a pull wire from the ruby coil pusher assembly was stuck within the returned handle.The proximal end of the pull tube was kinked within the handle.The nose cone was removed from the handle body and the funnel hole was found to be damaged.The nose cone funnel hole was measured with pin gauges and was within specification.Conclusions: evaluation of the returned handle and ruby coil pusher assembly revealed a damaged nose cone and the pull tube from the ruby coil pusher assembly was kinked at its proximal end and stuck within the handle nose cone.If the ruby coil pusher assembly is forcefully inserted into the handle nose cone, damages such as these may occur.During functional testing, the pull tube was removed from the handle, and the handle was tested on the handle test fixture and performed within specification.The complaint indicated that the ruby coil was implanted without issue.Penumbra coils and handles are visually inspected and functionally tested during incoming inspection.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: 3005168196-2020-00987.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10309457
• Report Number: 3005168196-2020-00986
• Device Sequence Number: 10977944
• Product Code: HCG
• UDI-Device Identifier: 00814548018362
• UDI-Public: 00814548018362
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2020
• 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 Expiration Date: 09/08/2026
• Device Model Number: RBY4C0630-B
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F85751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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