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

Catalog Number	RBY2C0305
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
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: 3005168196-2019-01147.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician advanced a ruby coil into the target vessel with a lantern delivery microcatheter (lantern) and reported that the ruby coil was unable to detach using the handle.The ruby coil was therefore removed and was no longer used in the procedure.The procedure was completed using another ruby coil and the same handle and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated and pull tube was retracted on the proximal end of the pusher assembly.The pull tube was kinked approximately 4.5 cm from the proximal end.Bends and kinks were present throughout the pusher assembly.The embolization coil was detached from the pusher assembly distal detachment tip (ddt).Minor offset coil winds were present on the embolization coil.Conclusions: evaluation of the returned ruby coil revealed a separated pet lock on the proximal end of the pusher assembly and a detached embolization coil.This likely indicates that the handle was used successfully to separate the pet lock.If the pet lock is separated and pull wire is retracted out of the pusher assembly ddt, the embolization coil will likely detach from the pusher assembly.Based on the reported complaint and returned condition of the device, the root cause of the inability to detach during the procedure could not be determined.Further evaluation revealed kinks on the device.The kinks were likely incidental to the reported complaint.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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8691203
• Report Number: 3005168196-2019-01146
• Device Sequence Number: 2005884
• Product Code: HCG
• UDI-Device Identifier: 00814548018546
• UDI-Public: 00814548018546
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 05/14/2019
• 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: 09/26/2026
• Device Catalogue Number: RBY2C0305
• Device Lot Number: F86116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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